Job Description
We have an immediate opening in one of the Best MNC in India for the Role of Protocol Data Manager for Bangalore Location .having the largest process for Protocol Data Manager in India.
We are looking for candidate relevant experience of above 4 to 6 years of experience in Protocol Data Manager.
Location - Bangalore.
Job Description
4-7 years of extensive experience as a Protocol Data Manager or equivalent in the pharmaceutical industry; experience supporting review of laboratory data a plus.
Experience negotiating with and influencing others to meet challenging goals.
Must be self-motivated
Experience working with vendors who supply clinical data in electronic format.
Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies
Previous experience using project management techniques including prioritization methods and the ability to work on different projects simultaneously.
Previous experience working in a team environment within a matrix organization.
In depth knowledge of clinical research including Investigator site issues
Experience in effective implementation of data review/management plans/documents and document preparation.
Experience in all aspects of data management from CRF design to database lock within expectations set by management.
Experience in training less experienced data managers in system and study specific areas.
Knowledge of data review processes and Database Management Systems including eDC systems.
Knowledge of ICH-GCP guidelines regulatory guidelines/regulations.
Solid understanding of regulations
Knowledge of general clinical research including Investigator site processes.
Knowledge of the pharmaceutical industry including the clinical and regulatory components.
Knowledge of basic project planning and management methods.
Basic office tools (e.g. MS Suite); CDMS (e.g. Medidata Rave
Should be flexible to work in shift Timings.
Job Classification
Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any Specialization
Post Graduation: Any Postgraduate in Any Specialization, Post Graduation Not Required
Doctorate: Doctorate Not Required
Contact Details:
Company: Golden Opportunities
Location(s): Bengaluru
Website: http://www.gojobs.biz
Keyskills:
ICH - GCP Guidelines
Medidata Rave
Project Management
Clinical Research
EDC
Crf Design
Data Management
System Study
Medidata Rave oracle Inform
Project Planning
Protocol Data Manager
Clinical Data