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Covance
Clinical Research Associate
Clinical Research Associate 2
West Midlands
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Clinical Professionals
Clinical Research Associate
CRA / SCRA (Klinický výzkum je přidružený) - Praha
Rest of Europe
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| Company: |
Clinical Professionals |
| Category: |
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| Position: |
Senior Clinical Project Manager / Research Scientist |
| Area: |
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| Location: |
South , South East UK |
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| Notes: |
Senior Clinical Project Manager / Research Scientist - Fantastic Opportunity for candidates with a Scientific approach
Company Summary
Would you like the opportunity to work at a global level within rare therapeutics? Excellent opportunities are available with our client, a global pharmaceutical company based in the South for Clinical Project Managers to progress their career into senior positions. Our client is one of the largest and most widely respected pharmaceutical companies in the world. With a very strong product portfolio and successfully enhancing the quality of life of millions, you would not want to miss an opportunity in working for them! Based in Surrey / Sussex they offer a generous relocation package.
Role Summary
You will be accountable for all aspects of assigned Clinical Development and Medical Affairs clinical trials (Phase II through lifecycle management) including leading Clinical teams. Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for program level activities as assigned.
Key Duties and Responsibilities
*Accountable for the writing of clinical protocols and related documents in collaboration with the team senior management - Lead the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other functions.
*Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into protocol. Participate in development of effective working relationship with key investigators in assigned therapy area
*Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings, accountable for all internal meetings related to the clinical trial. Lead and matrix manage the global multidisciplinary Clinical Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
*In collaboration with the team senior management lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
*Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Manager in the Contract Management Department.
*Forecast trial resources needs: accountable for the development, management and tracking of trial budget working closely with the operations group. Accountable for accuracy of trial information in all trial databases and tracking systems.
* Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, submission documents, responses to Health Authorities questions.
*Participate in the on-boarding, and training of new staff. Mentor TA staff
Education and Experience Required
*Advanced degree or equivalent education/degree in life science/healthcare is required.
*MD or PhD desirable
*Technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
*Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment
*Experience in developing effective relationships with key investigators.
*Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
Key Words: Senior Clinical Trials Manager Senior Clinical Project Manager Senior Clinical Research Manager Senior Clinical Research Scientist Surrey Sussex South London Berkshire Hampshire Middlesex Essex Kent Relocatable |
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| Reference: |
J91273
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| Contact: |
Clinical Professionals |
| Phone: |
0118 959 4990 |
| Apply: |
Click Here
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