The Clinical Project Manager (CPM) will be responsible for the operational planning and oversight of delivery of early phase clinical trials normally conducted by an experienced full service CRO.
These studies are expected to be Phase 1 or Phase 2a/2b conducted in Europe and/or N America.
The CPM will work closely with the Chief Medical Officer (CMO) and other in-house cross-functional experts such as Discovery or Tech teams.
Responsibilities include the evaluation, selection, and management of CROs and other Vendors to plan and deliver individual studies. Vendors may include providers of Clinical Trial Supplies, or specialist evaluation expertise.
The CPM will be responsible for day to day interactions, issue management, and general guidance working with senior CRO and/or Vendor staff (ie Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology) and to interact and visit investigator sites, as required.
This individual will report into the Chief Medical Officer.
This is an in-house position, located in the Euston, London, UK office.
• Oversee performance of CROs, and other third party vendors, including co-monitoring, to ensure delivery of quality data on time, compliance with study protocol, and regulatory and safety compliance
• Identify areas requiring action, and escalate to CRO managers, and CMO, as appropriate
• Develop and maintain good visibility/motivating relationships with investigators and study staff
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study- specific manuals and procedures
• Provide Internal Sponsor reports of progress of each study including site activation, patient enrollment, costs, issue resolution.
• Oversight of investigational product (IP) supply, and CRO accountability and reconciliation process of material.
• Review or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related regulatory documents
• Support Regulatory activities and document production.
Five to eight years Clinical Operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process.
• Five years experience in managing regulatory clinical trials (multicenter/multicontinental ) with novel products in Europe and USA preferred
• Experience working with and managing vendors, including performance assessments, financial management (invoice review, change order management, budget reforecasting, etc.) and senior manager interactions required.
• Previous experience working with an electronic data capture system and CTMS system required
• Strong interpersonal, communication (electronic and verbal), and organizational skills
• Demonstrated ability to work independently as well as part of a Sponsor/Vendor study team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in dynamic start-up environment
• Availability for potential travel local and international.
• Must enjoy working in a high responsibility, motivated, small company environment
• Relevant Life Science degree
This is an exciting opportunity to join a London based tech company poised to start a Phase 2B pivotal study in USA and Europe.
Founded in 2013, and applying artificial intelligence approaches to reshape drug discovery and development, BenevolentAI is developing in-house candidates and actively acquiring additional Oral therapy assets from reg tox stage up to Phase IIb ready, across most therapeutic areas. We have raised c$100m to date and have funds ready to deploy on additional programmes.
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Source: Nature Jobs