Description
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:
* BS/BA degree in related discipline and 4 years of related experience; or,
* Equivalent combination of education and experience.
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 5 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.
SKILLS:
* 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.