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]