Opening for Clinical Data Manager | Gurgaon

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Clinical Data Manager | Gurgaon

Position Overview:

Provides clinical data management support and advice.
Reports to Sr. Data Manager / Team Leader.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Clinical, Medical, Statistics and Data Management team members.
 

Responsibilities:

Discrepancy/Query Management
Review Annotated CRF
Prepare, maintain and ensure the execution of Data Entry guidelines, Discrepancy/Edit Check documents, Quality Control Plans
Test and approve data entry screens
Test and approve discrepancy/edit checks
Track CRFs using electronic systems as required
Sign off on Database
Manage/Facilitate Final QC Activities
DB Lock/Unlock Activities
Creating the signature forms (Data Entry Receipt Log, Study Signature Log)
Maintaining Study Binder.
Communication with clinical sites to resolve outstanding data issues
Managing Study Timelines
Attend and participate in project team meetings
 

Requirements:

Bachelors degree in Life Sciences, Mathematics, Statistics, Computer Science or a Medical/Nursing qualification. 2-4 years of experience into Data Management activities (DE Screen Testing, Edit Check Creation and Testing, Query Management, Data Entry guidelines creation, DB Lock/Unlock) in the pharmaceutical industry or a clinical/health-related research organization. Understanding of clinical trial methodology and GCP. Experience and understanding of at least one clinical data management system (e.g. Clintrial, Oracle Clinical). Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities. Knowledge of Framemaker, PL/SQL, Inform and/or EDC systems an additional plus.

City

Gurgaon

Country

India [IN]

Opening for Senior Clinical Research Associate

Organization Overview

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title

Senior Clinical Research Associate

Responsibilities

Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet-i3 SOPs and/or client guidelines
Recruit investigators
Negotiate study budgets with investigators
Obtain, review, and process regulatory and administrative documents from investigator sites
Review and develop protocols
Review and develop CRFs
Coordinate and present at Investigators’ Meetings
Participate in proposal meetings with potential clients
Prepare and review Serious Adverse Event (SAE) reports
Prepare project management reports for clients, project personnel, and PharmaNet-i3 management
Resolve issues, questions, and requests for additional study supplies
Review and approve monitoring trip reports
Review and verify completed CRFs
Review clinical data in-house
Resolve queries of CRF data with study site personnel
Review Tables and Listings generated from study data
Author Clinical Study Reports
Train and mentor CRAs on monitoring, internal procedures, and query resolution
When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.
 

Requirements

Bachelor’s Degree or nursing credential
over three and a half years experience in clinical research and direct monitoring experience required.
Fluent in English
Ability and willingness to travel 50% of the time
Excellent organizational skills
Ability to manage time and work independently
Excellent written and oral communication skills
 

City

Taipei

Country

Taiwan [TW]

Region

APAC

Opening for Technical Lead Clinical Data Management

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Technical Lead Clinical Data Management

Responsibilities:

Provide clinical data management projects and oversight/advice to data management function in 50:50 ratios.
Verifies and approves time sheets of team members.
Distributes and assigns work to inVentiv Data Managers.
Update resource allocation sheet.
Assists with interviewing and training new hires as needed.
Conducts employee reviews for data management team as needed.
Attends and holds project team meetings as needed.
Attends GSK departmental meetings.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Clinical, Medical, Statistics and Data Management team members.
Reviews timelines and ensure they are met.
Mentors, counsels, and recommends termination of subordinate employees as needed.
Works as Primary Data Manager (PDM) on individual projects.
 

Requirements:

Bachelors’ degree in Life Sciences, Mathematics, Statistics, Computer Science or a Medical/Nursing qualification.
Data management skills with 5 years clinical data management experience in the pharmaceutical industry or a clinical/health-related research organization.
Understanding of clinical trial methodology and GCP.
Experience and understanding of at least one clinical data management system (e.g. Clintrial, Oracle Clinical).
Good verbal and written communication skills.
Ability to work on multiple projects, plan, organize and prioritize activities.
Knowledge of Framemaker, Inform or any other EDC systems an additional plus.
 

City

Gurgaon

Country

India [IN]

Opening for Technical Lead SAS Programming

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Technical Lead SAS Programming

Position Overview

Provides SAS / Statistical programming support & advice.

Assists with interviewing and training new hires as needed.
Reports to Client’s Senior SAS Programmer / Team Leader.Distributes and assigns work to SAS Programming Team.
Works with departmental managers to develop plans and timelines.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Statistics and Data Management team members.

Responsibilities:

Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans.
Provide statistical programming support to team primarily using SAS software:
Develop, test and produce derived datasets, tables, listings and graphs for clinical study reports.
Validate derived datasets, tables, listings and graphs for clinical study reports.
Importing and exporting data files.
Extraction of data from database (e.g. Clintrial)
Assist with Quality Control Activities
Assist with development of departmental guidelines in line with the standardization of programs and systems for the generation of CSR components.
Reviews clinical study reports as needed.
Reviews timelines to ensure they are met.
Reviews training manuals and signs.
Attends departmental meetings.
Attends and holds project team meetings as needed.
Conducts employee reviews for SAS programming team as needed.
Mentors, counsels, and recommends termination of junior employees as needed.
Verifies and signs each individual team member’s attendance.
Works with management to approve vacation requests from team members.
Generate and maintain study documentation.
Attend and participate in project team meetings.

Requirements

Bachelors degree in Statistics, Computer Science, Mathematics or related discipline.
Good SAS programming skills with 3 years experience in the pharmaceutical industry or a clinical research organization. Skills should include Base SAS, SAS Macro and SAS ODS. Basic understanding of Software Development Lifecycle. Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities.

City

Gurgaon

Country

India [IN]

Opening for Strategic Resourcing Quality Lead or Coordinator

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Strategic Resourcing Quality Lead or Coordinator

Position Overview:

This role is involved in maintaining the QA compliance activities for FSP business.

Growth:

Will get exposed to QA activities in all BUs of FSP like data management, Clin Ops, SAS, Biostats etc
 

Responsibilities

Will be working in ICH and GCP environments
Should possess good communication skills
Involved in internal Audits
Potential candidate should have out of box thinking and wide perspective of company and role
Should be well versed with QA metrics
Should be GCP trained professional
Good to have global exposure

Requirements

For QA coordinator Candidates should have 2-3 years of experience in corporate QA preferably with FSP/ CRO experience and For QA lead candidate should have 5-6 years of experience in corporate QA.
Should have working experience in ICH and GCP environments
Should possess good communication skills
Preferred have prior Audit experience
Should be a good team player
Potential candidate should have out of box thinking and wide perspective of company and role 
Should be well versed with QA metrics
Should be GCP trained professional
Good have global exposure

City

Pune or Hyderabad

Country

India [IN]

Opening for Statistical Programmer - I | Gurgaon

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Statistical Programmer - I | Gurgaon

Position Overview

Provides SAS / Statistical programming support & advice.
Reports to local India SAS Programmer / Team Leader.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Statistics and Data Management team members.

Responsibilities:

Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans
Provide statistical programming support to GSK team primarily using SAS software:
Develop, test and produce derived datasets, tables, listings and graphs for clinical study reports.
Validate derived datasets, tables, listings and graphs for clinical study reports.
Importing and exporting data files
Extraction of data from database (e.g. Clintrial)
Assist with Quality Control Activities
Assist with development of departmental guidelines in line with the standardization of programs and systems for the generation of CSR components
Generate and maintain study documentation
Attend and participate in project team meetings

Requirements

Bachelors degree in Statistics, Computer Science, Mathematics or related discipline.
Good SAS programming skills with 1 to 2 years experience in the pharmaceutical industry or a clinical research organization. Skills should include Base SAS, SAS Macro and SAS ODS. Basic understanding of Software Development Lifecycle. Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities.
 

City

Gurgaon

Country

India [IN]

Opening for Sr.CRA | China

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Sr.CRA | China

Responsibilities:

Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
Recruit investigators
Negotiate study budgets with investigators
Obtain, review, and process regulatory and administrative documents from investigator sites
Review and develop protocols
Review and develop CRFs
Coordinate and present at Investigators’ Meetings
Participate in proposal meetings with potential clients
Prepare and review Serious Adverse Event (SAE) reports
Prepare project management reports for clients, project personnel, and PharmaNet management
Resolve issues, questions, and requests for additional study supplies
Review and approve monitoring trip reports
Review and verify completed CRFs.
Review clinical data in-house.
Resolve queries of CRF data with study site personnel.
Review Tables and Listings generated from study data.
Author Clinical Study Reports.
Train and mentor CRAs on monitoring, internal procedures, and query resolution.
When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority.
 

Requirements:

Bachelor’s Degree or nursing credential
Three and a half years’ experience in clinical research, data management, or regulatory affairs
Twenty four months’ field monitoring or equivalent experience
Ability and willingness to travel 50% of the time
Excellent organizational skills
Ability to manage time and work independently
Excellent written and oral communication skills
 

Country:

China [CN]

Opening for Senior Medical Writer | Sydney, Australia

Organization Overview

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title

Senior Medical Writer | Sydney, Australia

Responsibilities

Manage medical writing projects according to SOPs and client standards, on~time and on-budget.
Prepare study-related clinical documents (e.g., protocols, clinical study reports, Clinical Trial Registry records), regulatory submission documents, publications (e.g., abstracts, manuscripts, posters), medical information letters, or other documents as assigned.
Perform quality control review of medical writing documents.
Assist in developing strategies for organizing and preparing regulatory and/or commercialization documents.
Mentor medical writers and other members of the project team who are involved In the writing process.
 

Requirements

Master's Degree in life science is must and should have strong commutation skills in English and Japanese language is preferable.
Five years relevant experience in scientific, technical or medical writing.
Experience in data handling and analysis.
Excellent writing. editing, and organizational skills.
Proficiency in word processing software.
 

City

Sydney

Country

Australia [AU]

Opening for Senior Clinical Data Manager | Mumbai

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Senior Clinical Data Manager | Mumbai

Responsibilities

Perform data review and query generation
Define edit checks to be programmed for the study /project
Review programmed edit checks
Track study progress and issue periodic status report
Update the data base to correct errors
Code Case Report Form(CRF) verbatim terms using Pharmanet/i3 or sponsor supplied dictionaries
Process electronic data received from outside vendors
Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor
Identify the achievement of milestones to the Lead Data Analyst, e.g., database status as "draft" or "final"
May act as Lead Clinical Data Manager for assigned studies or projects
May coordinate the work of Associate Clinical Data Managers assigned to the project
May provide training on data management procedures and system
May create data management plan for the study /project
May assist in the review of database design
May develop and design CRF's,or participate in the review of sponsor-generated CRF
 

City

Mumbai

Country

India [IN]

Opening for Senior BioStatistician | Hyderabad

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Senior BioStatistician | Hyderabad

Position Overview:

Provide scientific statistical support & advice.
Represents Biostatistics and Data Management (BDM) on project teams, coordinates BDM project related activities and develops plans and timelines for the statistical activity on delegated projects.
Assists with interviewing and training new hires as needed.
Reports to Director of Biostatistics and Data Management.
Works across international and functional boundaries as needed within a project team environment.
Works closely with Clinical, Medical, Statistics and Data Management team members.

Responsibilities:

Provide scientific statistical input to development plans and to project planning.
Provide study design recommendations and prepare sample size calculations for Outline Protocols.
Prepare statistical section for Clinical Study Protocols.
Generate randomisation schedules for clinical trials in accordance with protocols and maintaining security of schedules before and during the studies.
Review Clinical Protocols.
Provide input to the design of Case Report Forms and review discrepancy/edit check specifications.
Approve Case Report Forms
Prepare Statistical Analysis Plans.
Interact with Statistical programmers regarding programming requirements for analysis and reporting.
Perform and Validate/QC statistical analysis.
Prepare the statistical section of Topline and Final Clinical Study Reports.
Review Final Study Reports.
Present and discuss results with internal/external bodies as required.
Hold project team meetings as needed.
Generate and maintain study documentation
Attend and participate in project team meetings

Requirements:

MSc in (Bio) Statistics from a recognized institution (like e.g. Indian Statistical Institute), MPhil a plus. Three to Five years experience as a statistician (not as a programmer) in pharmaceutical industry or a clinical research organization with responsibilities in clinical trial analysis and reporting. SAS programming skills. Knowledge and experience in pharmacokinetic studies required. WinNONLIN experience highly desirable. Experience with the following methodologies desirable: General Linear models - ANOVA, ANCOVA, t-test, F-test, etc (mixed models a plus); Non Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression. Familiarity with relevant GCP/ICH/FDA regulations. Excellent verbal and written communication skills in English. Ability to work on multiple projects, plan, organize and prioritize activities.

City

Hyderabad

Country

India [IN]

Opening for Safety Associate II | Pune

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Safety Associate II | Pune

Position Overview:

This role is majorly involved in case processing, and possibly quality review.

Responsibilities

Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
Prepare safety data reports for submissions to clients
Prepare expedited Safety Reports for submission to Regulatory Authorities
Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
Communicate with Clinical Operations and clients to ensure compliance with safety and pharmacovigilance SOPs
Assist in compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports
Assist the safety lead for projects; to include set-up, project management, client liaison
Perform literature searches
Assist with SAE reconciliation
Maintain current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting
 

Requirements:

Candidate should have 2-3 years of experience in Pharmacovigillance with core case processing experience. ARGUS database experience preferred
Bachelors / master’s degree preferably in pharmacy, life science, Ayurveda medicine (allied medicine), MSc (Microbiology, biotechnology).
Local Candidates will be preferred.
Possess good communication skills

City

Pune

Country

India [IN]

Opening for Payroll Supervisor

Organization Overvie:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Payroll Supervisor

Requirements:

5 Years relevant experience of processing Indian Payrolls
Statutory Knowledge
Understand tax calculations
Ability to calculate Full and Final Settlement Calculations
Professional qualifications
APAC experience (preferred)
Knowledge of ADP
Benefits experiences / processes (PF forms etc) Experience of handling PF transfers essential
Modern approach to data management and control
Excellent Microsoft Office skills
Understand financial aspects of payroll, GL’s, Balance accounts, works closely with Financial controller
Experience of Payroll Implementations i.e. experience of implementing new payroll software
Project Management skills
 

City

Gurgaon

Country

India [IN]

Opening for Medical Writer II | India

Organization Overview

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title

Medical Writer II | India

Position Overview

Develops documents supporting clinical drug development, including regulatory documents (eg study reports, protocols, and investigator brochures), publications
(eg abstracts, posters, and manuscripts), medical information letters, or other data-driven documents.

Responsibilities

Develops tables, charts, figures, and other display elements for clinical data.
Responsible for complying with client or company procedures for completing deliverables, obtaining reviews, incorporating edits, and working with teams to completelfinallze deliverables.
Keeps supervisor and team members informed of project status. Participates in team meetings.
Has working knowledge of drug development process and regulatory guidelines.
Responsible for continuing professional development to keep pace with regulatory guidance and client expectations, and to improve skills. Affiliates with professional organizations and participates in continuing education programs, conferences. seminars. and workshops, as circumstances permit.
Stays aware of the budget specifications for all assigned projects. working within the budgeted hours and communIcating any changes to specifications to the

Opening for Data Entry - QC | India

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Data Entry - QC | India

Position Overview:

This role is responsible for maintaining track of and entering all relevant data into time tracing systems.
Responsibilities This role is responsible for maintaining track of and entering all relevant data into time tracing systems.
Data entry of all application trouble shooting issues

Requirements:

Candidate should posses 2-3 years of experience in data entry activities, prior experience data entry into Elipsys and Plan view tools is more desirable but not mandatory
Should posses high proficiency in MS office tools
Should posses excellent verbal and written communication skills
Bachelors degree in any domain
 

City

Hyderabad

Country

India [IN]

Opening for Technical Lead Clinical Data Management at inVentiv Health Clinical

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Technical Lead Clinical Data Management

Responsibilities:

• Provide clinical data management projects and oversight/advice to data management function in 50:50 ratios.    
• Verifies and approves time sheets of team members. 
• Distributes and assigns work to inVentiv Data Managers. 
• Update resource allocation sheet. 
• Assists with interviewing and training new hires as needed. 
• Conducts employee reviews for data management team as needed. 
• Attends and holds project team meetings as needed. 
• Attends GSK departmental meetings. 
• Works across international and functional boundaries as needed within a project team environment. 
• Works closely with Clinical, Medical, Statistics and Data Management team members. 
• Reviews timelines and ensure they are met. 
• Mentors, counsels, and recommends termination of subordinate employees as needed. 
• Works as Primary Data Manager (PDM) on individual projects. 

 

Requirements:

• Bachelors’ degree in Life Sciences, Mathematics, Statistics, Computer Science or a Medical/Nursing qualification. 
• Data management skills with 5 years clinical data management experience in the pharmaceutical industry or a clinical/health-related research organization. 
• Understanding of clinical trial methodology and GCP. 
• Experience and understanding of at least one clinical data management system (e.g. Clintrial, Oracle Clinical).     
• Good verbal and written communication skills. 
• Ability to work on multiple projects, plan, organize and prioritize activities. 
• Knowledge of Framemaker, Inform or any other EDC systems an additional plus. 

 

City:

Gurgaon

Country:

India [IN]

Opening for Scientist - Nutrition & Med Affairs | Gurgaon

https://careers2.hiredesk.net/viewjobs/JobDetail.asp?Comp=I3&sPERS_ID=&TP_ID=8&JB_ID=&PROJ_ID={CFDFBC91-D8EF-4E09-B787-89203CBACAA6}&LAN=en-US&BackUrl=ViewJobs/Default.asp

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

Title:

Scientist - Nutrition & Med Affairs | Gurgaon

Position Overview:

To create new claims opportunities for the existing products within the product portfolio in Family Nutrition by developing innovative research or leading a review of existing scientific literature
 

Responsibilities:

• To create new claims opportunities for the existing products within the product portfolio in Family Nutrition by developing innovative research or leading a review of existing scientific literature
• To oversee the development of science into consumer friendly claims language and own the commercialization of claims including the Claim Support Summary documents.
• To manage the delivery of the new claims programs that contributes to the growth requirements of the Business.
• To provide effective Scientific & Technical knowledge for Family Nutrition in support of the business purpose.

 

Requirements:

• PhD in a health science or nutrition field with minimum 2 years of post doctorate experience, or of MSc with a minimum 5 years of experience in a related field, with substantial demonstrated competence in managing multiple, complex projects. 
• Knowledge of running clinical trials especially nutrition trials under ICH-GCP guidelines. 
• Significant practical experience related to claims research, preferably in the Food & Drinks industry. 
• Ability to design, implement and manage intervention studies in human subjects in conjunction with external centers of excellence 
• Comprehensive knowledge and understanding of key trends in nutrition and healthcare 
• Knowledge of Consumer Marketing techniques. 
• Must be able to interpret scientific data and information on products and to communicate this information in such a way as to enhance current strategic and promotional activities. 
• Demonstrated ability to co-ordinate team and project activity, including operating with external partners. 
• Track record of managing multiple projects successfully. 
• Demonstrated ability to apply scientific principles and techniques to assigned projects. 
• Demonstrated ability to take initiative, think and work independently, problem-solve, work in teams and multitask. 
• Knowledge of R&D process and associated commercial environment 
• Computer literate; familiarity with statistics and project management principles 
• Behavioral Skills & Competencies 
• Excellent team working and people leadership skills 
• Strong written and oral communications skills with demonstrable skills in oral presentations to both internal staff and other functions. 
• Demonstrated structured creative thinking and Innovation skills 
• Self-reliant, flexible, with good time management skills with ability to operate in an empowered environment. 
• Demonstrated significant personal achievement in previous roles. 
• Collaborative style. 
• Excellent influencing and negotiation skills and the ability to work closely with commercial functions and external research agencies. 

 

City

Gurgaon

Country

India [IN]

Opening for Cilincal Data Manager at inVentiv Health Clinical

https://careers2.hiredesk.net/viewjobs/JobDetail.asp?Comp=I3&sPERS_ID=&TP_ID=8&JB_ID=&PROJ_ID={4FFB56A0-2BB5-4E4F-86B8-3A16FB3FE763}&LAN=en-US&BackUrl=ViewJobs/Default.asp

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Cilincal Data Manager | Mumbai

Responsibilities:

• Perform data review and query generation 
• Define edit checks to be programmed for the study /project 
• Review programmed edit checks 
• Track study progress and issue periodic status report 
• Update the data base to correct errors 
• Code Case Report Form(CRF) verbatim terms using Pharmanet/i3 or sponsor supplied dictionaries 
• Process electronic data received from outside vendors 
• Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor 
• Identify the achievement of milestones to the Lead Data Analyst, e.g., database status as "draft" or "final" 
• May act as Lead Clinical Data Manager for assigned studies or projects 
• May coordinate the work of Associate Clinical Data Managers assigned to the project 
• May provide training on data management procedures and system 
• May create data management plan for the study /project 
• May assist in the review of database design 
• May develop and design CRF's,or participate in the review of sponsor-generated CRF 

Requirements :

• 3-4 years of experience in DM activities 
• Preferred to have candidates worked in OC-RDC environment 
• Should be involved in DM reviews and DM listing activities 
• Should have involved in DCF creations 
• Should posses good communication skills 

City:

Mumbai

Country:

India [IN]

QA Senior Manager–Hyderabad

Primary Location:

IND-Andhra Pradesh-Hyderabad

Organization:

Mylan Laboratories Limited

Description

For Us, It’s A Mission

At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.  If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.
 
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.
Here’s how this role will help:

• Establishing adequate measurements to monitor areas performance and participating in the control and auditing of manufacturing and packaging operations to assure conformance of products. 
• Managing the Quality Assurance areas and staff to achieve effective and efficient operations and communicating control policies, CGMP regulations and requirements to Quality Assurance, manufacturing and packaging personnel 
• Conducting audits of  Manufacturing and  Packaging Records and QA process related documents to assure that documentation is free of errors and complies with GMP’s and SOP’s. 
• Representing the Quality Assurance Department, in the absence of the QA Director during regulatory in-plant inspections 
• Initiating or revising department SOP’s in order to comply with quality standards.  Reviewing and approving company SOP’s as required; Reviewing existing control/manufacturing operations and provides innovation of more effective/efficient techniques 
• Ensuring that Quality Assurance area goals and objectives can be accomplished in a timely manner; Providing a positive, highly professional environment that can promote open communication, creativity and continuous improvement attitudes;  Enforcing safety rules and attitudes to promote a healthy environment 
• Selecting, training and evaluating the performance of personnel.  Recommending compensation changes in a timely manner.  Planning and providing developmental opportunities for personnel in both technical and management areas to increase productivity and encourage job satisfaction 
• Reviewing and approving Quality Assurance and production investigation reports as required.  Evaluating investigation reports and all related documentation for compliance with GMP’s, SOP’s and pharmaceutical regulations
   
  

  Qualifications

  Make Our Values Your Values
  Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.
• Here are the qualifications for this position:
• Minimum of a Bachelor's degree in Science or equivalent 
• 2-4 years of experience in a management or supervisory position (a combination of experience and/or education will be taken into consideration) 
• Must possess in-depth knowledge of the entire manufacturing/packaging processes and pharmaceutical industry 
• Must possess extensive knowledge and interpretation of established standard operating procedures and the current Good Manufacturing Practices, FDA, MHRA and other pharmaceutical related regulatory agencies 
• Plan, coordinate and audit all the phases of the Quality Assurance personnel functions in support of overall plant business objectives 
• Excellent communication and Writing Skills (Spanish and English) 
• Must have good working relationship with co-Workers and Management personnel and strong supervisory and leadership skills 
• Ability to write, review and maintain QA Standard Operating Procedures and other related documents 
• Good organizational skills for tracking and reporting duties are also required in addition to basic computer skills.

• Why Mylan?

  If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 20,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
   
  Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. Mylan is an Equal Opportunity Employer.
   
   
   
  

  Schedule Full-time

  Job Posting Sep 5, 2013, 1:24:53 AM
  Unposting Date Ongoing

Opening for Associate Cilinical Data Manager at inVentiv Health Clinical

https://careers2.hiredesk.net/viewjobs/JobDetail.asp?Comp=I3&sPERS_ID=&TP_ID=8&JB_ID=&PROJ_ID={28374927-A090-4F94-9807-FC6B56136DDA}&LAN=en-US&BackUrl=ViewJobs/Default.asp

Organization Overview:

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.

Title:

Associate Cilinical Data Manager |Mambai

Responsibilities

Perform data review and query generation
Assist in defining edit checks to be programmed for the study /project
Review programmed edit checks
Track study progress and issue periodic status report
Update the data base to correct errors
Code Case Report Form(CRF) verbatim terms using Pharmanet/i3 or sponsor supplied dictionaries
Process electronic data received from outside vendors
Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor
Identify the achievement of milestones to the Lead Data Analyst, e.g., database status as "draft" or "final"
 

Requirements:

1-2 years of experience in core Clinical Data Management.
Should possess good communication skills
Candidate who could join and could start working on assigned project right away is preferred (with minimal Project-specific training)
 

City

Mumbai

Country

India [IN]