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Job Details

Senior Clinical Trial Manager (m/f)

Company: Docs Global (Continental Europe)
Location: Darmstadt,Germany
Reference: Ref AS-024196
Closing Date: 23 Mar 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For one of the most successful global players in the pharmaceutical industry DOCS is hiring several Senior Clinical Trial Managers (m/w). If you want to develop further into Clinical Trial Management and by doing so, helping to improve treatment of today’s biggest challenges to public health, than this might be for you. As a Clinical Trial Manager you are responsible for planning, coordinating, preparing and conducting complex clinical trials, including the budget within...

Requirements:

Roles & Responsibilities of the position

• Collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards and services
• Acts as functional lead for process improvement initiatives
• Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
• Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form and other key protocol/program documents and activities
• Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection) and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
• Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post marketing commitments and Biosimilars
• Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies and promptly responding to action items
• Develops and leads the presentation on trial status to Integrated Clinical Study Committee and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
• Qualifies operational feasibility and establishes and analyzes protocol-level budget and grants throughout the life cycle of the trial
• Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
• Drives oversight of CROs and vendor management at trial level according to the applicable partnership model

Job Requirements

• Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent
• Working knowledge of GCP/ICH requirements, international regulatory guidelines and the drug development process
• About 6-8 years of professional experience in clinical research with at least 3 years in clinical trial management
• Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning) and in executing the complete range of clinical trial activities from start up through final trial report
• Proven track record of having successfully led one or more multinational trials
• Solid leadership and problem solving skills
• Fluency in English (oral and written)

Remuneration & other details

Conditions:
• Long term need, but due to new law 18 months fix term contract via DOCS with good chances to change to a perm contract with the client afterwards.
• Full time, ideally office based in Frankfurt/Main area. Home office options can be discussed.
• Great pipeline of studies -> very good long term perspective.
• Top 4 global player in the pharmaceutical industry.

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Interested? Please submit your CV to timo.kindermann@docsglobal.com or call me on +49 (0) 89 244 407 113. We are looking forward to your application.

Apply for this job: Senior Clinical Trial Manager (m/f)

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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