Sr. Clinical Trial Manager
OrciTrials
Remote
Job description

Sr. Clinical Trial Manager-USA

Salary: Competitive

Location: Cincinnati, OH

The Role

Sr.Clinical Trial Manager;

The Company:

Leading CRO for Biotech companies is looking for multiple Sr. Clinical Trial Managers.
Focused Therapeutic areas: Oncology/Haematology, Cardiovascular/Metabolic, Infectious Disease, CNS and more.

The Role Main Responsibilities:

  • Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
  • Serve as primary Sponsor contact for operational project-specific issues and study deliverables
  • Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
  • Develop operational project plans
  • Manage risk assessment and execution
  • Manage study vendors where applicable
  • Ensure that clinical trial deliverables are met according to timelines to achieve study goals, while meeting Good Clinical Practice (GCP) guidelines.
  • Lead a global cross-functional Clinical Trial Team (CTT), composed of internal and external team members
  • Management of Contract Research Organizations (CROs) supporting the clinical trial to ensure data integrity and quality.
  • Supervise CRO during study start-up, such as site initiation visit (SIV) meeting planning, case report form development for database, study drug supply design and ordering, and review study site contracts and budgets.
  • Provide review and input to the development of study start-up materials such as the clinical trial protocol, protocol amendment(s), Informed Consent Forms, Pharmacy Manual, Monitoring Plan, Laboratory Manual, and site training materials of the protocol.
  • Monitor the study budget; review and approve study-related invoices.
  • Review site qualification reports and approve site selections.

Additional Skills & Qualifications:

  • Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred
  • Experience in Phases 1-4; Phases 2-3 preferred
  • 5+ years as a project/clinical trial manager within a CRO
  • Management of overall project timeline
  • Bid defense experience
  • Strong leadership skills

Job Type: Full-time

COVID-19 considerations:
All customers are required to wear a mask, curbside pickup available, common surfaces are sanitized regularly, vaccination requirements etc.

Education:

  • Bachelor's (Required)

Experience:

  • project/clinical trial manager within a CRO: 5 years (Required)

Work Location: Remote

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