Clinical Trials Manager
An exciting opportunity has arisen for a Clinical Trial Manager to join a global biopharmaceutical company based in West London. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
The Clinical Operations team is responsible for the execution of all Phase 1-3 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of the company's products. For the team based in our European Headquarters in Uxbridge, we are looking for a Clinical Trial Manager to work within the Inflammation therapeutic area.
- Inflammation experience is not essential but a nice to have. They must have PAN European CT Experience and a minimum of 2 / 3 years.
- Manages European component of global Phase 2 3 outsourced studies managed by a Clinical Program Manager.
- 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 to 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 contribute to development of abstracts, presentations, and manuscripts.
- Ensures effectiveness of site budget/contract process.
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
- Conducts monitoring/co-monitoring as required.
- Assists in determining the activities to support a projects priorities within functional area.
- Coordinates and supervises all aspects of a clinical study.
- Under supervision, may design scientific communications within the company.
- Assists Clinical Operations Europe Therapeutic Area Lead in their duties as applicable
- Contributes to Clinical Operations Europe team activities & initiatives
- May serve as a resource for others within the company for clinical trials management expertise.
- Under general supervision, is able to examine functional issues from an organizational perspective.
- Provide strategic guidance of junior staff given acute insight on the monitoring of clinical sites.
- Partners with Clinical Program Managers and Managers in other functions, providing input where key decisions impacting business operations will be made.
- Actively involved in solving critical issues, applying previous knowledge and sometimes without precedents to meet schedules.
- Demonstrates knowledge of how clinical trial operations impact the broader, short-term strategic goals of the Company.
- Understands how the design and operations of clinical trials impact the goals of various functions.
- In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
- Coaches members of a work team and ensures adherence to established guidelines.
- Provide input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
- Anticipates obstacles and client difficulties and implements solutions to achieve project goals. Assists CPM in revising project timelines/budgets as necessary.
- Works with management on departmental issues, providing input to clinical operations strategies and work plans.
- Communicates with functional peers regarding project status and issues and ensure project team goals are met.
- Participate in training of CPAs and CRAs.
- Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.
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 call Matthew Pike on +44 207 440 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.
£0.00 - £60000.00 per annum
ProClinical is advertising a vacancy for a Biostatistical Programming Manager
ProClinical is advertising a vacancy for an Associate Manager, Business Development
€0.00 - €150000.00 per annum
ProClinical is advertising a vacancy for a Head of Research and Development Quality
An international health consulting company is seeking applicants for an RA Specialist vacancy
San Mateo, California
ProClinical is advertising a vacancy for an Administrative Assistant
ProClinical is advertising a vacancy for an Operations Regulatory CMC Analyst
ProClinical is advertising a vacancy for a Drug Safety Manager
ProClinical is advertising a vacancy for a Regulatory Affairs Manager
ProClinical is advertising a vacancy for a Quality Compliance Specialist III position
ProClinical is advertising a vacancy for a Quality Assurance Specialist III position
ProClinical is advertising a vacancy for a Brand Insights Manager vacancy