An exciting opportunity has arisen for a Contract Clinical Study Manager to join a global biopharmaceutical company based in the United Kingdom. A very patient focused company, who scientific research has resulted in 15 marketed products that are benefitting hundredsof 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.
Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Company's operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.
For the team based in our European Headquarters in Uxbridge, we are looking for a Clinical Trial Manager to work within the Inflammation Disease therapeutic area.
Essential Duties and Job Functions:
- Manages European component of global Phases II-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 project's 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 the 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.
- Works with Clinical Program Managers to manage the European component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
- Interacts with cross-functional teams internally and externally to ensure trial progress.
- Will incorporate study logistics and planning to accomplish study objectives.
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
- Knowledge, Experience and Skills
- Inflammation therapeutic area experience would be advantageous but not essential
- Must have multinational (including EU) clinical trials experience including study management/coordination.
- Must have solid previous study management/coordination experience.
- Must have monitoring experience as site monitoring and/or co-monitoring will be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is essential.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
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 +44 203 7520 314 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.