Clinical Trial Manager - Gene Therapy
ProClinical is advertising a vacancy for a Clinical Trial Manager specialising in Gene Therapy to join a leading pharmaceutical research company. Based in the company's London office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.
- Manages European component of global Phases II-III outsourced studies.
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
- Maintains study timelines.
- Contributes development of study budget
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Manages CROs/vendors.
- Coordinates review of data listings and preparation of interim/final clinical study reports.
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements and cell therapy logistics.
- Assists in determining the activities to support a project's priorities within functional area.
- Under supervision, may design scientific communications within the company.
- May assist Clinical Operations Europe Therapeutic Area Leads in their duties
- Contributes to Clinical Operations Europe team activities & initiatives
- May serve as a resource for others within the company for clinical trials management expertise.
Skills and Requirements
- Must have a degree BS in science related field
- Oncology/Cell Therapy experience is essential for cell therapy and desirable for oncology.
- Must have multinational (preferably EU) clinical trials experience including study management/coordination.
- Monitoring experience highly desirable as site oversight monitoring visits will be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Must be able to generally understand, interpret, and explain protocol requirements to
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/send-cv
A full job description is available on request.