About the position
The Clinical Trial Manager is a highly autonomous and experienced professional responsible for overseeing all aspects of Clinical Trial Management for global studies at Summit. This role encompasses the entire lifecycle of clinical trials, from study start-up through to close-out, ensuring that all performance metrics and quality deliverables are met. The Clinical Trial Manager coordinates and leads cross-functional team members, Contract Research Organizations (CROs), and vendors to successfully deliver clinical studies. This position requires a strong focus on maintaining study scope, quality, timelines, and budget, while fostering solid professional relationships with key opinion leaders and clinical site staff. In this role, the Clinical Trial Manager partners with the CRO to develop and implement effective patient enrollment strategies, ensuring that enrollment is completed on time. They are also responsible for ongoing data monitoring strategies to guarantee the delivery of high-quality data. Proactive identification and management of study-related risks are crucial components of this position. The Clinical Trial Manager will develop and manage essential clinical trial documents, including protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements, while also reviewing and managing study-related plans and processes. The Clinical Trial Manager will oversee the maintenance of the Trial Master File (TMF) and ensure its completeness at the end of the study, performing periodic quality control checks. They will also ensure compliance with Good Clinical Practices and national and international regulatory requirements, maintaining an “inspection ready” status for the study at all times. Additionally, this role includes oversight and coaching of Clinical Trial Associates allocated to the project, as well as other duties as assigned.
Responsibilities
- Oversees study scope, quality, timelines, and budget with internal functional leads, CRO, and vendors.
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff.
- Partners with the CRO to develop and implement robust patient enrollment strategies.
- Partners with the CRO to ensure effective ongoing data monitoring strategies are in place.
- Proactively identifies and manages study-related risks.
- Develops and manages clinical trial documents including protocols, CRFs, consent documents, and confidentiality agreements.
- Reviews and manages study-related plans and processes including investigator agreements and monitoring plans.
- Reviews CRO and vendor contracts/work orders to meet study objectives.
- Reviews essential document packages for timely site activations.
- Reviews pre-study, study initiation, interim monitoring visit, and study closeout visit reports.
- Provides oversight on monitoring report findings and updates the broader team.
- Directs investigator performance and addresses conduct issues and enrollment problems.
- Oversees the maintenance and completeness of the TMF at the end of the study.
- Performs periodic quality control of the TMF.
- Ensures compliance of clinical trials with regulatory requirements and company SOPs.
- Ensures the study is always 'inspection ready'.
- Oversees and coaches Clinical Trial Associates allocated to the project.
- Performs all other duties as assigned.
Requirements
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
- 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization.
- Prior phase II and III experience required.
- Solid understanding of the drug development process, ICH guidelines/GCP, and clinical trial processes.
- Experience with budget forecasting and management.
- Experience with clinical studies in oncology.
- Ability to travel internationally to visit clinical sites and for study meetings (up to 20%).
- Proven proficiency in overseeing large complex studies managed in-house and by a CRO.
- Demonstrated ability to lead teams and work in a fast-paced environment.
- Experience in building relationships with KOLs and site personnel.
- Ability to engage and work collaboratively with overseas clinical operations team members.
- Demonstrated ability to build and deliver on patient enrollment strategies.
- Excellent interpersonal and decision-making skills.
- Demonstrated ability to comprehend complex scientific concepts and data.
- Proficient in reviewing and assessing clinical data.
- Excellent planning, time management, and coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements and timelines.
- Experience in working in a small organization.
- Excellent written and oral communication skills.
Benefits
- Health benefits
- 401(k) with 6% employer match from day one
- Employee Stock Purchase Plan (ESPP) with a 15% discount up to the federal limit
- Flexible spending account
- Bonus, stock, benefits, and/or other applicable variable compensation.
