Company: INC Research
Location: UK Regional, European Locations
Closing Date: 16 Mar 17
Salary (£): Negotiable
Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensures the scientific integrity of the clinical portions of clinical trials; provides medical input to clinical programs; provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.
•Manages subject safety and the scientific integrity of clinical trials.
•Responsible for subject-safety and the scientific integrity of clinical trials.
•Performs the duties of a Medical Monitor.
•Provides 24-hour coverage for clinical trials.
•Participates in bids, bid-defenses & feasibility assessments when requested.
•Provides project-specific and therapeutic training to sponsors and Company staff as needed.
•Works with the Drug Safety Department by providing medical input and oversight.
•Works with Medical Writing/Regulatory in the preparation of a variety of documents as required.
•Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines.
•Interacts with senior management, project management, and other departments as appropriate.
•Provides clinical development and regulatory consulting advice both within Company and to clients as requested.
•Locates and interacts with outside experts as necessary.
•Provides feedback to management on quality issues within the clinical trial team
•Represents Company at scientific meetings as required.
•Primary senior-level contact for customers.
•Assumes line-management duties as needed.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined approach to work with excellent verbal communication and language skills. Fluency in written and spoken English.
European Head Office
River View, The Meadows Business Park,
|Tel:||+44 (0) 1189 335 300|
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