Senior Clinical Project Manager

About the Company

Full time, permanent role sponsor dedicated. 3 days in the office in Oxford is a must. Oncology Study.

About the Role

The Senior Clinical Project Manager (Sr. CPM) will be responsible for overall management and oversight of large complex contracted clinical studies and/or programs, including (but not limited to) development of project documentation, training project staff, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables. They will work to ensure that all aspects of the conduct of the study and/or program are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. The Sr. CPM will be asked to participate in the company’s process improvement initiatives. Additionally, they could mentor Clinical Project Managers and study support staff (e.g. Clinical Trial Managers, Clinical Trial Associates) and may have direct reports (e.g. Clinical Project Managers, Clinical Trial Managers, Clinical Trial Associates) across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost, and quality.

Responsibilities

• Ensure successful execution and oversight of assigned programs ensuring the program deliverables and milestones are met with quality and within budget.
• Provide oversight and accountability of all third-party vendors assigned to a program or assigned protocol.
• Play an active part in CRO selection and review of RFP’s when required, ensuring the appropriate CRO is identified and properly vetted.
• Work with internal and external teams as required, ensuring the company FIP/M development projects are initiated and managed in line with company strategy and key clinical and regulatory milestones.
• Review, negotiate and approve any required change orders.
• Develop and manage the overall study budget, forecast spend, and ensure study costs stay within predicted spend and identify and communicate study issues that will impact budget, resources and timelines.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines.
• Ensure program meets all GCP/ICH Guidelines and is Inspection Ready.
• Assist and contribute in authoring company study protocols, protocol amendments and other related study documents, as required, from the initial scientific discussion.
• Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection.
• Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals.
• Develop and operationalize biomarker strategies, when required.
• Establish, monitor and maintain procedures as required to ensure regulatory compliance of protocol activities.
• Contribute to IND development and other regulatory documents including but not limited to briefing books, regulatory submissions and responses.
• Contribute high level input to regulatory documents such as Investigator’s Brochures and development safety update reports (DSUR); with the ability to create and/or update these where necessary and asking for input where appropriate.
• Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones.
• Assist in SOP and working instruction development, review and approval within the company.
• If supporting a Phase FIH/P study, work closely with internal scientific, translational and clinical colleagues to deliver fit for purpose Phase I/Ib clinical studies in line with related regulatory requirements and internal quality processes.
• Contribute as required to the scientific, intellectual property, and business development aspects of the company’s activities in order to help fully realize their potential, such as; biomarkers, trial designs, FIH study designs/operational implementation and BLA/MAA filing support.

Qualifications

• BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline).
• At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management. Experience must include global/international studies or programs. Experience in infectious disease and/or oncology is highly desired.
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant IRT and EDC systems and programs.
• Experience with Vendor oversight.
• Experience with all aspects of the conduct of a clinical study including start-up through close out.
• Familiarity with global regulatory regulations and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, GDP and ICH GCP. Awareness of local country requirements is also required.

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