Clinical Data Manager
- Expired: over a month ago. Applications are no longer accepted.
Clinical Data Manager
Here at SRG, one of our top clients is looking to fill a Clinical Data Manager Role!
About the Opportunity
- Due to growth, our client's team is rapidly expanding
- Our client's cro specializes in a niche therapeutic area
- They have been in business for over 20 years
Duties of the Clinical Data Manager
- Provide data management expertise and support to internal project teams, clients and Clinical Research Organizations (CROs) including the following:
- study startup documents, data cleaning, DCF/query tracking, database QC, compilation, and maintenance of data management binders and/or files, and SAE/AE reconciliation
- Plan, perform and oversee development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review and execution of User Acceptance Testing
- Conduct and orchestrate scheduled cross-functional data review, identification of issues and track through resolution
- Participate in innovation and implementation of new technologies resulting in data management process improvements
- Ensure adherence to quality control procedures for data management activities
- Write appropriate Standard Operating Procedures (SOPs)/training guidelines and oversee revisions /updates to current SOPs/training guidelines for data management activities
- Facilitate and oversight of internal study team, client and CRO meetings
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to Director any requested out of scope activities
- Manage and monitor timelines and assuring resources are available to meet timelines
- Identify inconsistencies and inefficiencies in data management processes and recommend solutions
- Assist in preparation of proposals and budgets for new projects as well as manage budgets for ongoing projects
- Direct and manage team members in daily activities including providing training, resource assignment, adherence to timelines and conducting annual performance review.
What is Wanted for the Clinical Data Manager Role:
- 12 years data management experience, or B.S. /B.A. in a science or technical discipline degree with 8 years data management experience, or MS degree with 6 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
- Meet the requirements of a manager with a high degree of proficiency and autonomy
- 6 years’ experience supervising Clinical Data Managers and/or team activitie
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
- Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
SRGWhy Work Here?
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SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
AddressWake Forest, NC