Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Senior Clinical Trial Manager

Cambridge, MA 02139

Posted: 11/16/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2184

Our Client is looking to add a Senior Clinical Trial Manager to its team on a contract basis. 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.

Responsibilities:
  • 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
  • Assisting with the development of any new or updated SOPs/Work practices for the department
  • 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

Responsibilities/Qualifications:
  • Bachelor’ s Degree required, relevant scientific or health-care related discipline highly preferred
  • Minimum of 5-7 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
  • Ability and willingness to travel 5-10% of the time (international and domestic)

 

Julie Monti
Clinical Recruiter

Julie brings nearly 20 years of experience to her role as Clinical Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.

Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.