Clinical Data Manager
Artech Information Systems LLC
Company Description
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
• Project Data Management level.
• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
• Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.
• Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)
• Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution,
• Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.
Qualifications
Bachelor degree or above in scientific or related field Minimum 5-7 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must
Additional Information
Best Regards,
Anuj Mehta
Summary
- Type: Contract
- Function: Research
- Experience level: Mid-Senior Level
- Industry: Pharmaceuticals
Vacancy posted 2 days ago
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