Clinical Trial Manager / Senior Clinical Trial Manager

Clinical Development Cambridge, MA


Description

What’s in it for you?

Acceleron Pharma has an immediate opening for a Clinical Trial Manager / Senior Clinical Trial Manager. In this role, you will be responsible for clinical study management.  You will be a reliable team player who has the ability to work well cross-functionally in a fast-paced environment.

What will you be doing?

  • Managing the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work
  • Leading 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
  • Authoring and reviewing as needed clinical study documents (Informed Consent Forms, Clinical Study Plans, Case Report Forms, etc.).  Reviewing and contributing as needed to Investigator’s Brochure and other supportive regulatory documents
  • Driving IRB/ethics committee and regulatory submissions as needed to support study timelines
  • Effectively evaluating qualified study sites, performing site initiation, planning and presenting at investigator meetings/advisory boards, and implementing 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
  • Managing and reviewing study budgets and investigator grants
  • Overseeing 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 review of monitoring reports, and ensuring proper documentation is filed to meet GCP requirements
  • Assessing study drug requirements and shipment logistics; contribute to labeling strategy
  • Responsible for study close-out (CRO, third party vendors and internal close-out activities, invoice reconciliation for project closure) and ensuring study timelines are met
  • Reviewing, and contributing as needed, to support completion of the Clinical Study Reports
  • Overseeing TMF archival, submission and QC activities
  • Working efficiently, both independently and within a team
  • Training/mentoring junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned
  • Creation, training, review and approval of clinical operations program specific documents
  • May assist with the development of any new or updated SOPs/Work practices for the department
  • Trains and mentor junior staff or peer mentorship of new hires
  • Manages junior staff

What are we looking for?

  • Bachelor’s Degree required, relevant scientific or health-care related discipline highly preferred
  • Minimum of 4+ 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
  • Thorough understanding and ability to lead a cross-functional team through all activities in the full clinical study life cycle
  • 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
  • Management or mentorship experience
  • Ability and willingness to travel 5-10% of the time (international and domestic)

How will you grow with us?

As a member of the Clinical Operations team during an active period of growth at Acceleron, you will directly impact the success of assigned programs.  You will learn and develop through direct and hands-on experience and will be mentored by your manager and team.  This opportunity provides a tremendous opportunity to gain experience in clinical development in a dynamic, fast-paced, and innovative company.  Join our team and help us in our mission of transforming the lives of patients!

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit https://acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.