Senior Manager, Data Management Acceleron Pharma
THIS JOB HAS EXPIRED About Acceleron:
Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta protein superfamily, a large and diverse group of molecules that regulate the growth and repair of tissues throughout the human body, and in targeting these pathways to development important new medicines. Acceleron has built a highly productive R & D platform that has generated numerous innovative biologic therapies with novel mechanisms of action. These differentiated biologic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases. The investors in Acceleron have included: Advanced Technology Ventures, Alkermes, Avalon Ventures, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures, and Venrock. For further information on Acceleron, please visit www.acceleronpharma.com.
This position works with clinical, regulatory, biostatistics and contract data management organizations to ensure that data management activities are performed with quality according to project timelines. This position will manage all data management activities including the development of case report forms (CRFs), data management plans, edit specifications, and oversee CROs for query management as it pertains to clinical studies.
Works with clinical, regulatory, biostatistics and contract data management vendors/CROs to design and review clinical study documents including but not limited to protocol, case report forms, clinical database, edit check specifications, data review and reconciliation.
Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies.
Oversee and perform, as necessary, the following tasks:
Lead data management contact for oncology program
Drive study setup, maintenance and lock activities
Plan and perform user acceptance testing of clinical database (CRF and edit checks)
Generate, review and approve data management plans
Review and approve data transfers and other deliverables from external sources
Lead cross-functional discussions to define data handling and database design standards
Define and manage timelines to meet deliverables on time and with quality
Generate and disseminate project status reports to management
Manage CRO/data management specific vendor activities, timelines, and budgets
Lead new data management initiatives such as evaluating technology vendors i.e. electronic data capture, authoring SOPs and guidelines, and establish data collection and reporting standards based on CDISC.
Bachelor?s degree required. Requires 7-10 years? experience in Pharmaceutical or Biotech Clinical Data Management
Proficient in computer technology used in an office environment (Microsoft Word, and Excel)
Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations.
Experience with Medidata RAVE, SAS and Coding tools.
Awareness and familiarity of statistical methodology.
Ability to solve complex problems in all areas of data management
Ability to provide leadership on a cross-functional team
Strong project management skills
Effective communication skills, both verbal and written
Ability to work independently
Strong attention to detail
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED