Senior Clinical Data Manager

San Francisco  ‐ Onsite
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Keywords

Description

Designs, implements and maintains clinical trial database for new and ongoing clinical research studies. Manages clinical database activities including: archiving of clinical data and clinical study databases, security administration, electronic data received from clinical trial sites and vendors, and the development of technical study documents such as annotated case report forms.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Provide a high level of expertise in data management to support clinical studies.
* Provide clear verbal or written information and hands-on support to project team members and to CROs related to CRF design, data quality, and reporting of study results.
* Manage data transfers with CRO's, SAE/AE reconciliation and Med DRA coding semi-automated processes.
* Support IND Reporting and the transfer, locking, and archiving of study databases. Manage scheduling and time constrains across multiple projects.
* Prepare recommendations for new or improved processes for data management and data flow.

EDUCATION/EXPERIENCE/SKILLS:

Education:
* BS/BA degree in related discipline and seven years of related experience; or,
* MS/MA degree in related discipline and five years of related experience; or,
* PhD in related discipline and two years of related experience, or;
* AA degree with RN
* Equivalent combination of education and experience.
* May require certification in assigned area.

Experience:
* Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry preferred.
* A minimum of 3 years of clinical data management experience is also required, some of which is preferred to have been in the pharmaceutical industry or clinical trials.
* Experience with electronic Clinical Database Management Systems is required and experience with electronic reporting applications preferred.
* Experience with electronic data capture (EDC) is preferred.
* Experience as a lead clinical data manager is preferred.
* Experience with oncology clinical trials is preferred.
* Experience with Phase III clinical trials is preferred.

Knowledge/Skills/Abilities:
* Knowledge of GCP is essential.
* Has extensive experience in relevant industry/profession and area of specialization.
* Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
* Identifies and implements methods and procedures to achieve results.
* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has complete understanding and wide application of technical principles, theories, concepts and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills

To find out more about Real please visit www.realstaffing.com
Start date
05/2013
From
Real Staffing
Published at
28.04.2013
Project ID:
528737
Contract type
Freelance
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