The RoleThe Clinical Trial Manager (CTM) will be a key contributor to the successful execution of clinical trials and will play an important role in building and maintaining relationships with investigators, study site personnel, CRAs, CRO teams, and external vendors.
Leveraging a strong understanding of clinical trial execution, the CTM will oversee day-to-day clinical trial operations, including clinical project management, study site activities, CRA monitoring activities, and vendor management.
The CTM will work closely with cross-functional study teams to ensure assigned clinical trials are executed according to established timelines, quality standards, budgets, and applicable regulatory requirements.
Key Responsibilities- Manage and lead the day-to-day operations of assigned clinical trial(s), ensuring execution against established study goals, timelines, and objectives and in compliance with applicable GCP/ICH guidelines and regulatory requirements.
- Participate in and, depending on study scope, lead cross-functional study teams, including CROs and external vendors.
- Coordinate with internal functional areas to ensure effective execution of clinical study activities.
- Support laboratory-related study activities, including understanding study sampling requirements and providing oversight of laboratory vendors in collaboration with cross-functional teams.
- Develop and/or contribute to informed consent forms (ICFs), study training materials, and study-specific tools.
- Provide Clinical Operations input into protocols, ICFs, CRF design, monitoring conventions, edit checks, and vendor specifications.
- Review, approve, and provide timely sign-off on key study documents.
- Provide sponsor oversight of CROs and third-party vendors to ensure compliance with study protocols, contractual requirements, timelines, and defined scopes of work.
- Monitor CRO and vendor performance, identify potential issues, and escalate concerns to Clinical Operations leadership when appropriate.
- Interpret study protocols and effectively communicate protocol requirements to study teams, sites, and external partners.
- Proactively identify study risks and develop mitigation strategies in collaboration with cross-functional stakeholders.
- Manage study timelines, milestones, and deliverables and provide regular progress updates to management.
- Develop and maintain study metrics and tracking tools, including patient visits, data entry, monitoring activities, data cleaning, and other key operational indicators.
- Support study financial management activities, including review of contracts, budgets, invoices, and statements of work.
- Contribute functional Clinical Operations expertise to the development and implementation of SOPs.
- Partner closely with Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other functions throughout study execution.
- Support study inspection readiness and ensure appropriate documentation and processes are maintained throughout the clinical trial lifecycle.
Desired Experience & Qualifications- Bachelor's degree in life sciences, healthcare, or a related discipline.
- Minimum of 5 years of clinical trial management experience within the pharmaceutical, biotechnology, or CRO industry, with progressively increasing Clinical Operations responsibilities.
- Strong understanding of the complete clinical trial lifecycle, from study start-up through close-out.
- Experience supporting inspection readiness activities.
- Experience providing oversight of CROs and external service providers.
- Experience managing or supporting international clinical trials, including studies conducted across multiple global regions.
- Oncology clinical trial experience preferred.
- Working knowledge of GCP, ICH guidelines, FDA regulations, and other applicable clinical research requirements.
- Strong understanding of cross-functional clinical development disciplines, including Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance.
- Demonstrated ability to lead effective study team meetings and facilitate cross-functional decision-making.
- Strong judgment with the ability to proactively identify, communicate, and resolve study-related risks and issues.
- Excellent verbal and written communication skills with the ability to effectively interact with internal and external stakeholders.
- Strong organizational and prioritization skills with the ability to work independently and manage multiple priorities.
- Ability to travel approximately 5-10%, including domestic and international travel.
