Sr. Clinical Data Manager (Contract) (RE-12450096) South San Francisco, California

Salary: GBP1 - GBP22 per annum

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.