Senior Clinical Project Manager

Job Description

CK Group are recruiting for a Senior Clinical Project Manager to join a promising and well-backed biotechnology company with pipeline programs developed through early clinical development process. The position will be remote with some office attendancerequired on site in Cambridge.RESPONSIBILITIES:As Senior Clinical Project Manager you will have operational responsibility for outsourced clinical development studies from start-up to close-out. This key role will lead the planning, and oversee the day to day execution of clinical studies to the requiredlevel of quality, including creating and managing study timelines, budgets, third party vendor partners and study management plans in accordance with GCP and regulatory requirements.Key duties will include:

• Oversee and manage all aspects of study progress from planning to close-out to ensure adherence to intended timelines and budget, and achievement of study goals while ensuring quality in accordance with all appropriate regulatory, GCP, and ICH guidelines
• Collaborate effectively with other key trial functions (e.g. Translational Medicine, Medical, Stats/DM, Regulatory, QA), both internally and externally, to deliver successful trial execution.
• Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
• Lead the evaluation, selection and management of third party vendors (e.g. Contract Research Organisations (CROs) and other external vendors) to ensure successful clinical trial implementation and execution. Drive the development and operational input intoMSAs/WOs.
• Create, manage, and execute clinical operations programs, including study management
• Drive the development and ensure execution of activities outlined in various study plans alone and in partnership with third party vendors (e.g. Clinical Study Sponsor Oversight Plans, Medical Management)
• Ensure development of and, as appropriate, author components of key study documents such as clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
• Develop and execute TMF strategies for each trial
• Develop and execute risk assessment strategies for each trial
• Co-monitor or monitor studies as needed for the program
• Liaise and build strong relationships with third party vendors, clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
• Participate in preparation of regulatory filings (e.g. CTA/IND filings, briefings for regulatory meetings, orphan applications etc.) as needed
• Expect to play a key role in the development and maintenance of key clinical operations SOPs and process that support an outsourced/oversight model of clinical development.

Experience/ Required Qualifications:

• Post graduate degree preferred in a scientific or healthcare discipline
• Minimum of 10 years in clinical and drug development in the pharmaceutical/biotech industry, at least 5 years of direct study management work preferred in outsourced models
• Understanding of drug development from pre-CTA through marketing authorisation applications
• Participation in regulatory authority inspections/audits
• Extensive experience managing clinical programs, complex, multi-part early phase protocols, third party vendors, budgets, and timelines required
• Strong working knowledge of planning tools (MS Project, Smartsheets or alternatives) and developing Gantt charts
• Excellent oral, written, and medical communication skills required
• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
• Protocol, ICF, and CSR writing experience desirable
• Proven experience in the oversight of the operational aspects of all stages of clinical studies
• A detailed understanding of overall strategic direction, interrelationships and business needs of small organisations is highly desirable

Apply:It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55810 in all correspondence.