Senior Clinical Trials Manager 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 is responsible for overall clinical study management. The successful candidate will be a reliable team player that has the ability to work well with many different functional areas including regulatory affairs, program management, medical research, data management and drug supply. This thoughtful individual will support the overall program development strategy and program goals to ensure the highest scientific/medical standards are met. Working with a team of engaged colleagues, this person will be responsible for the achievement of goals that are consistent with the overall corporate vision, mission and objectives.
Team oriented individual who is able to:
Work efficiently both independently and with a team.
Manage the selection, contract/budgeting and supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work.
Lead both an internal and external/CRO 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.
Author clinical protocols with a protocol development team. Author and review as needed other associated clinical study documents (Informed Consent Forms, Clinical Study Plans, Case Report Forms, Statistical Analysis Plan, etc.). Review and contribute as needed to Investigator?s Brochure and other supportive regulatory documents.
Drive IRB/ethics committee and regulatory submissions as needed to support study timelines.
Effectively evaluate qualified study sites, perform site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study (e.g., investigator binder, pharmacy binder, regulatory binder development, etc.) in collaboration with the clinical study team.
Manage and review study budgets and investigator grants.
Oversee interim study conduct including management of operations/medical questions from CRO and sites, planning and facilitation of interim safety meetings, tracking subject recruitment, laboratory samples, and study drug supply, review of monitoring reports, and ensure proper documentation is filed to meet GCP requirements.
Assess study drug requirements and shipment logistics; contribute to labeling strategy.
Responsible for study close-out and ensuring study timelines are met.
Assist in the development of internal clinical SOPs.
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 highly preferred
Minimum 5-8 years of clinical trial management experience including protocol development, selection and management of CROs and contract vendors, timeline management, and budget management. Prior experience working in the biopharmaceutical industry is required
Demonstrated proficiency in management of multi-center international clinical trials (from initiation to closure)
Experience managing outsourced work
Excellent interpersonal, communication (written and verbal), time management, presentation and organizational skills
Ability and willingness to travel 5-10% of the time (international and domestic)
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED