In collaboration with study team and external vendors: designs, implements and maintains electronic case report forms, clinical trial database and electronic edit checks for new and ongoing clinical research studies. Develops, implements and executes data review plans to ensure quality of collected clinical data. Manages electronic data received from specialty vendors (e.g. clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics.
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 database / data quality status.
- Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
- Support 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.
- 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.
- 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.
- Knowledge of GCP is essential.
- Expertise in CDISC standards preferred.
- 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.
- 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.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job