A leading biotechnology company is seeking to recruit an Senior Clinical Manager, Clinical Operations to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.
Job Responsibilities:
Contracts & Budgets:
- Initiate Change Order (CO) and Change Negotiation Form (CNF) for vendors in collaboration with Business Operations
- Ensure invoice review of vendors, track vendor spend against plan and provide vendor budget updates to SETL
- Provide monthly accrual for vendors to SETL
- Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDev
Clinical Operations Managed Vendors & CRO:
- Ensure vendor oversight plan is created and maintained
- Contribute to the selection of CRO and vendors
- Contribute to the development of standard metrics used to routinely monitor study activities
- Perform day-to-day management of the CRO and other vendor(s) as needed
- Monitor all vendors/CRO performance, communicate vendor expectations, and track vendor performance metrics at a study level
- Ensure that vendors/CRO are adequately trained to perform their functions
- Escalate vendor/CRO issues to the SETL when appropriate
Protocol & Informed Consent Form (ICF) Development Process:
- If assigned prior to protocol finalization, provide input to the protocol development
- Serve as protocol subject matter expert for assigned study or studies
- Actively contribute to the review of amendments to the protocol
- Ensure creation and maintenance of tracker for future amendment changes
- Contribute to the review of amendments to the ICF Master
- Develop country/site specific ICFs
- Ensure alignment of country/site specific ICFs with ICF Master
Study Start Up:
- Translate study start up requirements into regional/local targets
- Ensure development and review of study specific documentation
- Lead country and site feasibility assessment, as appropriate
- Select potential qualified sites to participate in the study
- Lead confidentiality agreement execution, budget and contract negotiation with selected sites in collaboration with Legal and Business Operations
- Ensure regulatory document collection and tracking is performed for sites participating in studies
- Lead Institutional Review Board/Ethics Committee (IRB/EC) related activities from submission to approval
- Confirm that all site level documents have been collected to support site initiation
- Lead process for the release of IP and ensure timely availability of drug at the sites
- Schedule and facilitate investigator meeting(s)
- Develop site training materials for the study
- Ensure accuracy of information for their study presented in study weekly dashboard(s)
Study Conduct And Close-out:
- Monitor study enrolment and retention and act on deviations from plans
- Identify barriers to enrolment and support recruitment and retention strategic solutions
- Monitor and act upon study metrics - (review, trend-identification and analysis, with targeted follow up where appropriate)
- Review Monitoring Visit Reports
- Identify, resolve and escalate issues relating to study delivery, timelines and site budget to SETL
- Ensure accuracy of information for their study presented in study weekly dashboard(s)
- Manage all study close-out activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
- Coordinate and oversee data listing reviews
- Ensure timely delivery of clinical documents for the Clinical Study Report (CSR) and appendices
- For global, multi-country studies, SOL may oversee all Regional Operations Lead (ROL) study conduct activities in each region of study execution across startup, enrollment and maintenance, and close-out
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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