Data Management Contractor Acceleron Pharma
THIS JOB HAS EXPIRED About Acceleron:
Founded in 2003, Acceleron Pharma, Inc. is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. We have internally discovered and developed 4 products that have entered into human clinical trials. Acceleron has raised over $130M in venture financing and secured an additional $180M from collaborations with Celgene Corporation, Alkermes, and Shire. Acceleron?s scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF--- protein superfamily. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company?s internal GMP manufacturing capability to advance its therapeutic programs rapidly and efficiently. The investors in Acceleron include Advanced Technology Ventures, Alkermes, Bessemer Ventures, Celgene, Flagship Ventures, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock.
We are seeking talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success.
This position works with clinical, regulatory, and contract research organizations (CROs) to ensure that data management activities are performed with quality according to project timelines. This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision.
Works with clinical, regulatory, and CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format
Manages the CROs to ensure that data management tasks remain on target according to project timelines
Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies
Participate in data management initiatives such as evaluating technology vendors i.e. electronic data capture, SOP authoring and reviewing, and establish data collection and reporting standards
Bachelor?s degree required. Minimum of 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, and has related database experience
Capacity to learn and navigate through different data management systems (Oracle Clinical, Clintrial), EDC (Inform, Rave, OC-RDC), and SAS
Understanding of CDISC STDM, and eCTD submission requirements
Coding experience using MedDRA and Who Drug dictionaries
Ability to work independently with minimal supervision and excellent written and oral communication skills are required
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED