Clinical Data Manager - PGx Health
- Job ID:
- Date:12/10/2008
- Location:New Haven
- State:Connecticut
- Salary:Not Specified Why?
- Job Types:
-
CLINICAL AFFAIRS, Pharmaceutical Regulatory Affairs
Job Description
This position is part of the clinical development team and reports to the V.P. of Regulatory and Clinical Development. Responsible for managing the conduct of clinical trials and associated activities related to PGxHealth’s Phase III investigational product in development for a myocardial perfusion imaging agent.
Clinical Data Manager
Duties and Responsibilities
Development/Testing of Case Report Forms, Edit Check Specification, Completion Guidelines and Data Handling Plan for paper or electronic studies.
Perform Quality Reviews of the RDC system using Oracle Clinical (or any CDMS), SAS, IR and Discoverer.
Create Ad Hoc listings/reports using SAS and other tools as appropriate
Utilizes tools/systems to code medical terms/medicines
Review and approve Data Management Plans prepared by CROs
Receive and review all deliverables and ensure the CRO is meeting all deadlines
Act as point of contact for the CRO on all Data Management issues
Complete CRF reviews and audits of CRO documentation, including query generation for missing or discrepant data
Attends weekly meetings with CRO and internal study team members to resolve project related issues
Assist with data management for NDA filings
Key Relationships
Internal:
External:
Managerial Relationships
Direct:
Indirect:
Background Requirements
Education, Experience, and Knowledge
Education
Bachelor's degree in Life Sciences, Pharmacy or Nursing
Experience
3+ years in clinical data management in a CRO/Pharmaceutical/Biotech environment
Skills and Abilities
Solid understanding of Phase I, II, and III studies from study start to database lock for RDC and Paper studies, including database design and clinical data management process
Excellent organizational management with leadership experience in dealing with CROs is essential.
Comfortable working with MS Office and Data Management tools: SAS, Oracle, Clintrial, Electronic Data Capture and other DM software.
Other skills/abilities include involvement in NDA submissions, ability to understand programming language (SQL, SAS), Medical coding, SAE reconciliation, multi-tasking, problem solving and effective verbal/written skills.
NOTE: This job profile describes the duties and requirements of the position. Requirements stated are representative of minimum levels of knowledge, skills and/or abilities required to successfully perform the job. The employee may be asked to perform other job-related duties as required.
Please send salary requirements along with resume.
CLINICAL DATA IS AN EQUAL OPPORTUNITY EMPLOYER.
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