PDM-Protocol Data Manager
- Golden Opportunities
- 4 - 7 Years
- Chennai
- 6 years ago
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Job Description
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 with the ability to follow through on assignments without direct supervision very attentive to detail' capable at multitasking across projects and able to effectively contribute in a team environment.'
- 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 important milestones and strategies to ensure timelines are met.
- 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 GCPs 21CFR Part 11 and data privacy as they apply to data handling and the use of computer systems in clinical research.
- 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 Oracle Clinical INFORM etc..); J-Review; SAS programming will be a plus
- Should be flexible to work in shift Timings.
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: Pharmaceutical/BiotechnologyRole Category: Other PharmaRole/Responsibilies: PDM-Protocol Data ManagerContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
Keyskills: Protocol Data Manager medidata Rave oracle Inform
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