Contract - Clinical Trials Management 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, Celegene, 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.
We have an immediate opening for a Clinical Trials Manager for a 6 month contract position. This position is responsible for overall clinical study management. A team player that has the ability to work well with many different functions to support the overall program development strategy and program goals ensuring the highest scientific/medical standards are met and to achieve goals that are consistent with the overall corporate vision, mission and objectives.
Team oriented individual who is able to:
Assist in the selection, management, and contract/budgeting of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work.
Able to lead a study management team, to ensure the successful conduct of clinical trials in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs.
Responsible for co-reviewing clinical protocols and associated documents (Case Report Forms, Statistical Analysis Plan, Monitoring Plan, Data Management Plan, etc).
Responsible for site selection, site initiation, and study start up activities including development of documents related to conduct of the study (ie: investigator binder, pharmacy binder, regulatory binder development, etc) in collaboration with the clinical study team, study budgets and investigator grants.
Responsible for study conduct including organization of appropriate study conduct and safety meetings, tracking subject recruitment, laboratory samples, study drug supply, SAE tracking, and monitoring report review in collaboration with the clinical study team.
Assesses study drug requirements and shipment logistics; contributes to labeling strategy.
Ensures proper documentation and filing of clinical study conduct.
Responsible for study close-out and ensuring study timelines are met.
Support the overall clinical development strategy and program goals ensuring the highest scientific/medical standards are met and to achieve goals that are consistent with the overall corporate vision, mission and objectives.
Bachelor?s Degree required, relevant scientific or health-care related discipline preferred
Minimum 5-7 years of clinical trial management experience, timelines management, budget management, and management of CROs and contract vendors
Demonstrated proficiency in management of multi-center global clinical trials (from initiation to closure)
Experience managing outsourced work
Effective interpersonal, communication (written and verbal), time management, presentation and organizational skills
Flexibility to accommodate travel up to 10-15%
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED