Essential Skills and Duties/Responsibilities:|
- Reviews protocols and provides input to clinical protocols relevant to data management issues.
- Serves as the company's lead and liaises with CROs regarding all Data Management functional responsibilities.
- Reviews and approves all relevant data management documentation received from CROs (i.e., data management and handling plans and timelines, edit check specifications, clinical data query handling and resolution, database validation protocols and documentation) and/or internal documentation.
- Works with senior clinical development personnel to assess and select CROs and/or internal resources to perform data management functions.
- Provides input for the development of project specific and clinical program timelines and budgets.
- Manages and performs User Acceptance Testing of EDC systems for use in active clinical studies.
- Organizes and maintains the internal electronic clinical data server and develop relevant SOPs.
- Mentors, manages and leads staff in setting personal goals, clarifying expectations and job accountabilities.
The qualified candidate will have a Bachelor’s Degree in Life Sciences or Mathematics and/or formal or on-the-job training in clinical trial methodology and Good Clinical Practice (GCP); eight or more years of experience in drug development and the discipline of data management; three or more years of experience in management and/or business operations; appropriate experience with an understanding of multiple clinical data management systems (e.g., Medidata Rave, Oracle Inform, Merge eClinical OS); CRF design and CDASH experience; SOP development, training and implementation experience; working knowledge of regulatory guidances and mandates; good organizational and documentation skills; and team player who works effectively with other disciplines. Some travel will be required.
Physical Demands/Work Environment:
This position is office-based; sitting and computer use up to eight hours per day.
The salary for this role is 90-100K and begins Feb 2013.
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 550,000 employees annually.
Revenue in 2011 was $5.6 billion.
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Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
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