Clinical Trials Manager (Biotechnology/Oncology)

Role Summary

The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).

Responsibilities

• Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
• May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
• Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
• Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
• Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
• Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation
• Coordinates the preparation, conduct, and presentations at Investigator Meetings
• Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
• Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials
• Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
• Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines
• Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed
• Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP))
• Ensures oversight of regulatory and essential documents
• Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
• Coordinates the design, format, and content of study guides and subject instructions
• May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
• May support / be responsible for site and vendor invoice reviews
• Reviews and provides oversight of study trackers and metrics
• Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
• May be responsible for department strategic initiatives or process improvements
• May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)

Qualifications

• BA/BS in biological sciences or related field and a minimum of 7 years of related experience; or
• MS in biological sciences or related field and a minimum of 5 years of related experience; or
• PhD in biological sciences or related field and zero or more years of related experience; or
• Equivalent combination of education and experience.
• Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research

Knowledge/Skills

• Experience in either starting a study up, maintenance phase, or study close-out
• Experience with development of prospective site-selection criteria
• Protocol development experience
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Familiar with advanced concepts of clinical research
• Ability to deal with time demands, incomplete information or unexpected events
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Demonstrated ability to write and present clearly using scientific and clinical issues terminology
• Strong organizational and planning skills
• Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment
• Ability to understand technical, scientific, and medical information
• Demonstrated success in problem-solving

Job Complexity

• Ability to anticipate and resolve problems
• Ability to write and present clearly, especially on scientific and clinical issues
• Ability to work effectively in a team/matrix environment
• Demonstrated professional collaboration skills
• Understands departmental processes and implements solutions to address any task-related challenges
• Identifies and escalates issues that may have a broader impact

Additional Requirements

• Travel may be required up to 20% in support of clinical study activities