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- Oxford, UK
- Full-time employment
- Posted on 10 Nov, 2018
- Start date:
- Visa Sponsor
The Clinical Project Manager role is an EU role, based in the UK. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies, within Adaptimmune’s programs.
The CPM will be responsible for EU clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, site selection, start up, study conduct, data cleaning, data review, and study close-out, for one or more clinical trials.
- Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs
- Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution
- Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)
- Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally
- Provide guidance on protocol and procedures in the development of eCRF design
- Review monitoring visit reports; liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions
- Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place
- Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing
- Study specific vendor interaction and coordination
- Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects
- Maintain TMF and ensure inspection readiness
- Proactive stakeholder management and communication of progress and issues
Qualifications & Experience
Minimum of a BA/BS in Life Sciences Degree
Previous leadership in a matrix environment
Extensive experience in clinical project management of industry-sponsored clinical trials. Experience in Oncology trials is required, biologics or cell and gene therapy is a plus
Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials within the oncology area
EDC including trial management, data review, issuing and resolving queries, CRF design/review/ approval
Prior experience with clinical protocol development and/or regulatory submissions and management
Additional post-graduate scientific experience or qualifications, such as an M.Sc. or PhD
Skills & Competencies
Describe required and desirable skills and competencies needed to successfully perform the role.
Strong interpersonal and communication skills (both spoken and written) – with ability to effectively communicate on project planning, progress, tracking etc.
Strong relationship building skills to work effectively with others in various disciplines and levels
Strong leadership and negotiation skills with ability to employ different styles and/or strategies depending on team- members and situations
Proven ability to manage multiple, complex and competing priorities to effective and efficient conclusion
Project experience leading cross-functional teams in a matrix environment
Experience working cross-culturally a plus
Ability to operate strategically and tactically
Sense of urgency and ability to work effectively to timelines
Highly motivated, independent and a self-starter
Decision Making Authority
Study execution decisions – including planning and risk mitigation. Decisions impacting clinical trial delivery, speed, quality and cost.
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Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.
Our proprietary SPEAR T-cell platform has
- Health & Social Care, Science & Research, Chemicals & pharmaceuticals
- Abingdon, UK
- 201-500 employees
- Founded in 2008