LEAD EDC Programmer (Data Systems and Programming Manager)
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. Maintains a clinical trial database for new and ongoing clinical research studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develops expertise in advanced clinical and/or technical implementation of Global Library maintenance.
- Ensures that selected Clinical Development employees are appropriately trained to take maximum advantage of the installed clinical systems. Oversees training and qualifications of all users including the maintenance of appropriate documentation.
- Collaborates closely with Data Management and Statistical staff to develop electronic case report forms and prepares edit check specifications; database maintenance and development of new database applications
- Provides primary day-to-day support of users of computer applications for the development of pharmaceutical products, (2) adapt, configure, and customize their multi-tiered applications, and (3) integrate the applications for the solution of business problems.
- Provides real-time support to help employees solve Access request needs and maintain productivity.
- May provide immediate supervision or assigns tasks to one or two vendor partners.
- Ability to manage multiple priorities, assess needs and adjust workloads. and communicate project status accordingly
- 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,
- Equivalent combination of education and experience.
- Experience in Biotech/Pharmaceutical industry preferred.
- Applies advanced technical principles, theories and concepts. Contributes to the development of new principles and concepts.
- Standardized data system design, development, and maintenance
- Standardized data analysis of clinical data
- Generation and quality assurance of summary tables and listings
- Experience in Clinical Development processes.
- Data transformation using mapping tools.
- CDISC standard schemas for clinical data.
- Proficiency in Clinical Data Management procedures including knowledge of Good Clinical Practices (GCP)
- Strong computer skills with proficiency in Medidata Rave, Oracle Clinical, MS Office
- Experience in creating reports in Cognos, Business Objects, and Spotfire
- Excellent written and oral communication skills
- Possesses extensive experience in relevant industry/profession and area of specialization.
- Utilizes professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Performs a variety of complicated tasks with a wide degree of creativity and latitude.
- Possesses a complete understanding and wide application of technical principles, theories, concepts and techniques.
- Holds a 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 of his or her own area of expertise.