Duke Street Bio
Senior CRA/ Clinical Trial Manager
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Clinical Trial Manager
Reporting to the Executive Director, Clinical Operations, the Clinical Trial Manager (CTM) supports the planning, execution, and reporting of clinical trials, ensuring they comply with regulatory requirements and good clinical practice guidelines. They may be responsible for a region and/or global activity within a workstream, within one or multiple studies. The CTM may take on additional responsibilities depending on the size and complexity of the study. The CTM is part of the Duke Street Bio study delivery team.
Responsibilities
- Clinical project management of a region or study
- Oversee activities of one or more third-party vendors/ CRO(s)
- Ensure regulatory compliance and GCP compliance
- Participate in Risk Management for the study(ies) assigned
- Provide input on operational aspects of the protocol and other key study documents/ plans, including ongoing evaluation of process improvement
- Manage study(ies) in accordance with relevant study plans and all associated documents
- Collaborate with the DSB/ CRO team to plan and coordinate IMP and non-IMP supplies, and oversee management of clinical samples
- Plan, facilitate and document meetings as required
- Ensure quality delivery of study operational activities including but not limited to:
- Feasibility and Site Selection
- Regulatory/ IRB/ IEC Submissions and approvals
- Site Contracts/ Agreements
- Essential Document collection and approval
- Clinical Monitoring/ Site Management, including visit report review and follow up
- Protocol Deviation management
- Trial Master File, including conducting periodic Quality Reviews
- Facilitate site engagement, attending Site Visits as required
- Contribute to the development of proactive strategy and corrective action plan to address study issues in collaboration with appropriate Clinical Operations team members
- Assess and manage key study performance information, including but not limited to; study start-up, enrolment, data management and TMF metrics
- Contribute to data cleaning planning and progress
- Participate in review of data as required, and support EDC/ IRT activities (e.g. User Acceptance Testing)
- Provide regular updates to Duke Street Bio leadership
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Education
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A bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or a related health/medical field is preferred. Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).
Experience
- A minimum of 5 years’ relevant clinical research experience within the pharmaceutical industry
- Experience in early phase clinical trial management
- A solid understanding of the drug development process, with awareness of cross-functional activities
- Experience in overseeing clinical trial activity, with preference for experience in managing in an outsourced model
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Ability to work independently with some oversight in the support and/or management of clinical trial execution.
- Oncology experience is desirable
- Experience working with a small biotechnology company is desirable
Location
Remote-based (UK, Spain)
No agencies please.
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