Clinical Data Manager Post in inVentiv Health Clinical in Gurgaon

Clinical Data Manager Post  in inVentiv Health Clinical in Gurgaon

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.

Post: Clinical Data Manager

Job Description: 

  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

Candidate Profile:

 
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.

Additional Information:

  Experience: 2-4 Years

Location: Gurgaon

Industry Type: Pharma/ Biotech/Clinical Research

End Date: 25^th Aug, 2013

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