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