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.
• Experience with electronic Clinical Database Management Systems is required and experience with electronic reporting applications preferred.
• Experience as the lead data manager for a phase 3 trial is preferred.
• Experience in the oncology therapeutic area 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.


JOB COMPLEXITY:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.