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Job Details

Clinical Scientist & Development Project Manager

Company: Advanced Clinical Recruitment Ltd
Location:
Reference: JC6
Closing Date: 17 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

If you are interested in this excellent opportunity, please do reach out so we can discuss further. My direct line is (0044) 114 - 294 - 5005 or alternatively email me directly on jcoomey@acr-uk.com

Requirements:

The Clinical Development Project Manager is responsible for all aspects of the operational conduct of assigned clinical trial(s), including contribution to protocol development and other critical documents, leading the clinical trial team (vendor management), leading and organizing the conduct of the assigned trials, in compliance with GCP, according to budget and in collaboration with internal and external partners, such as internal scientist, consultants, vendors / CROs, clinical site operational staff and investigators.

 

Responsibilities:

  • Managing trials from start to finish in the indications of the company’s focus.
  • Organization, contributing and leading the clinical trial protocol development process and be accountable for the preparation of clinical protocols
  • Participating in developing and maintaining effective relationships with key investigators and key opinion leaders to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Organize and manage investigator meetings. 
  • Planning and executing of all operational aspects of the assigned clinical trial(s), including managing and interacting effectively with CROs and vendors. Oversee trial progress and design and implementation of project plan, including budget management
  • Contribute to report writing and preparation of documents for submission to regulatory agencies. ? In collaboration with Polyphor and CRO QA groups ensure compliance and GCP adherence of clinical studies and programs
  • In matrix environment, lead and manage the global multidisciplinary Clinical Project Team (CPT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures, to organize and chair CPT meetings, report study progress and issues with their resolution plan to Polyphor Management

Qualifications:

  • You hold a higher degree, Ph.D. (preferred) or M.Sc., in natural sciences or medical disciplines.
  • You have at least 8 years of practical experience gained from working in a pharmaceutical company or CRO.
  • Your combined scientific and operational hands-on /on-the-job experience in various disciplines related to and relevant for clinical development is given.
  • You are familiar with the drug development process, its related documentation and ICH and GCP requirements. 

Necessary key skills include the proven ability to work independently and in a highly organized way, to lead a multidisciplinary trial team. You should have thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and the global clinical development process. You have the experience in developing and maintaining effective relationships with key investigators. Advanced knowledge of oncology, hematology and/or antibiotic development would be an advantage. The role requires team player skills, self-motivation and initiative, reliability, efficiency, accuracy, flexibility and enthusiasm. You are fluent in English (oral and written), additional language skills (German/French) would be an asset. 

Apply for this job: Clinical Scientist & Development Project Manager

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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