Snr Clinical Program Manager
Russell Oakley is currently recruiting for a Senior Program Manager to join a global pharmaceutical company based in the Cambridge region. The position is permanent.
The main purpose of the Sr CPM of Global Clinical Study Delivery is: Plans and manages overall clinical operations strategy and execution for assigned clinical trial(s)/programs. The Sr CPM works collaboratively with Global Clinical Operational Strategy (GCOS) and with supervision from the Line Manager (LM) on timelines, budgets, resources, vendors and key project deliverables. The Sr CPM works in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with departmental strategies and goals and represents the functional area on cross-functional Clinical Trial Teams (CTT)s.
Further responsibilities will include:
Provides clinical operational expertise to deliver clinical trial deliverables from clinical protocol (CP) to clinical study report (CSR). Provides matrix management of functional area representation to cross-functional CTT(s). Leads/oversees multiple cross-functional CTTs. Defines and manages accountabilities for all CTT members. Manages the pre-determined clinical budget that rolls up into the PDT budget. Collaborates with cross-functional area heads to ensure proper resourcing for assigned trials. Accountable for providing operational input into the study protocol. Develops outsourcing specifications for vendor requests for proposal and scope of work agreements. Manages CTT in vendor selection. Manages the vendor(s) throughout the life of assigned clinical trial(s). Selects investigational sites with input from GCOS, Clinical Development, GCSD counterparts and external vendors. Reviews and refines study level Clinical Operations Plans (i.e., study monitoring, vendor operational plan, etc). Oversees investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs. Leads ongoing review of data to ensure quality and consistency. Plans and conducts investigator meetings and ad boards, etc. Develops and manages program budget(s) within constraints set by the LM and oversees site agreement/budget negotiation process. Manages projects to agreed program timelines. Oversees the submission of the trial-related and essential documents to the Trial Master File. Identifies and provides solutions to clinical trial operational issues. Provides input into non project related activities and development of procedures as requested. Mentors staff and serves as a resource for new employees. May provide mentoring to CPMs and/or A CPMs. Provides or facilitates training to clinical study teams on protocol specific topics. Participates as appropriate in internal and external audits. Other duties as assigned
In order to be considered for this role, you will be required to have the following qualifications, skills and experience: University degree in biologic or related scientific discipline or experience equal to the requirements of the position. At least 10 years of biotech and/or pharmaceutical industry experience in human drug development and including global drug development experience. At least 5 years managing within clinical projects and /or matrix teams within clinical operations across multiple phases and therapeutic areas and geographic areas.
For more information or to apply for this position, please contact Russell Oakley on 0114 2839956 or email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL29888 in all correspondence.