The Manager of Clinical Data is the internal resource for data management and biostatistics as well as outcomes research for Organogenesis. The main focus is on data management and biostatistics of clinical trials and real-world evidence.
Overall responsibilities will include coordinating, and hands on involvement, in data management and biostatistics tasks for prospective clinical trials, and publications of prospective and retrospective data, including liaising with external data management and biostatistics partners. The Manger of Clinical Data reports to the VP of Global Medical and Clinical Affairs and will be a contributing member of this overall team.
Provide early strategic input into the data management issues associated with clinical programs.
Develop for collecting‚ organizing‚ coding‚ storing and analyzing data for the company’s research purposes.
Engage in the design‚ documentation‚ testing‚ and implementation of clinical data collection‚ and clinical database management across multiple product lines and all phases of clinical development.
Collaborate and coordinate with others to assist in the design of clinical protocols‚ CRFs and statistical analysis plans.
Maintain responsibility for standardization of CRF design and data management conventions across multiple programs.
Coordinate activities of Contract Research Organizations and other 3rd party vendors specifically related to data collection and analysis.
Develop strong working relationships and maintain effective communication with clinical Affairs team.
Ensure proper validation of systems‚ conventions and procedures employed in data management processes.
Ensure data management requirements‚ associated timelines and budgets are well understood by clinical operations personnel and other personnel associated with data management functions.
Identify and manage the activities of external Biostatisticians
Provide data management and biostatistics support for publication activities.
Collaborate closely with medical writer and other members of medical affairs.
PREFERRED EDUCATION AND EXPERIENCE
The successful candidate will have some knowledge and experience of both areas of responsibility.
- Master’s degree in economics, health policy or related discipline, or a scientific discipline with minimum of 3 years' related experience desired. Education or training in biostatistics desired. Bachelor degree with extensive relevant experience considered.
- Exposure to outcomes-based strategies and tactics to meet commercial and scientific objectives, and pharmacoeconomic modeling a plus
- Understanding of the uses of real world evidence and comparative effectiveness for health policy decision-making is preferred
- Working knowledge of regulatory and commercial compliance issues relating to conducting research and disseminating of scientific information is important
- Expertise in the preparation of data management reports desired
- Experience or knowledge of conducting research studies applying health economics, patient-reported outcomes, retrospective and prospective data analyses, epidemiology or health services research desired
- Working knowledge of United States health policy and health care system stakeholders (i.e. managed care, public sector payers, emerging models of care) a plus
- Statistical and analytical skills would be important
- Experience with coding dictionaries (WHO‚ COSTART‚ ICD–9‚ MedDRA) preferred
- Proficiency with Microsoft Word‚ Excel and PowerPoint required
- Experience with database design and development expertise preferred
- Experience in SAS‚ Clinical trial and data management software‚ or SQL databases a plus
- Ability to handle multiple projects and work in a team environment is required
- Developing excellent internal and external collaborative relationships would be key to success
- Excellent skills in written and oral communication desired