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Job Details

Clinical Project Leader

Company: Key People Limited
Location: München (81249)
Reference: 1408-107
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits: Bonus + Relocation

Job Summary:

Key People are looking for a Clinical Project Leader to work for our biotech client based in the Munich area focusing on global trials

Requirements:

Key People are looking for a Clinical Project Leader to work for our biotech client based in the Munich area focusing on global trials

Main Responsibilities:

• Plan, implement and supervise clinical trials, working in close
collaboration with project leaders, clinical research physicians
and other stakeholders
• Oversee execution of one or more clinical trial, while ensuring
that all trial deliverables are met according to specified timelines,
budgets, and quality including CRO selection and management
• Define, negotiate and ensure execution of study-related agreements
with investigational sites, CROs, Central Lab Services etc.
• Contribute to preparation of clinical program documents, e.g.
investigator brochure, IND annual report, health authority
submissions etc.
• Develop study-related documents from concept sheets to final
documents and ensure resolution of critical issues
• Identify areas of best practice and contribute to process improvement
• Line Management of assigned staff

Minimum Requirements:

• Minimum of three years’ professional experience in multinational clinical
trial management, focusing on the pharmaceutical or biotech industry
• Proven track record of compiling clinical study protocols, reports and
publications
• Demonstrable expertise relating to all aspects of the clinical
development process
• Ability to identify and resolve complex methodological issues relating to
clinical trials
• Well-developed organizational and interpersonal skills, complemented
by attention to detail
• Good knowledge of GCP and regulatory requirements (especially FDA
and EMA)
• Fluent written and spoken English
• Willingness to travel (approx. 25%)

Apply for this job: Clinical Project Leader

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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