Company: Docs Global (Continental Europe)
Location: Utrecht area,Netherlands
Reference: Ref AS-018897
Closing Date: 26 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
You will be the central point of communication between the company and the investigator for all clinical trial related activities to assure trials are conducted on time and budget. You will lead the internal teams to coordinate on the local CPO and/or the global level for a combined portfolio of large and smaller clinical trials in different complexity levels.
Roles & Responsibilities of the position
- Participate in operational feasibility to assess feasibility of trial in Netherlands.
- Nominate new sites for clinical trials; analyze capability and make recommenda-tion for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and company line functions and increase value proposition to investigators.
- Facilitate preparation and collection of site level documents; resolve problems as required.
- Perform site selection visits.
- Create and oversee entire site management, including initiation and training, monitoring and close-out visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance.
- Track trial execution milestones; monitor trial costs; identify problems; resolve issues and escalate as appropriate.
- Manage recruitment and execute contingency plans, as needed.
- Assure preparation/generation of study monitoring reports.
- Conduct site contract negotiations.
- Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets.
- Act as local and/or global “Lead CRA” and author global monitoring plan.
- Act as a mentor to new associates, as assigned.
- Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
- A degree in a scientific or health care discipline preferred.
- at least 5 years experience in clinical research or having demonstrated adequate level of proficiency within the Trial Manager profile.
- Solid understanding of clinical trial design, trial execution and operations.
- Knowledge of international standards (GCP/ICH), international (FDA, EMA) and local regulations.
- Proven people management skills with demonstrated expertise in working on teams.
- Understand and apply medical and business knowledge to clinical trial execution.
Interested? For more information contact:
Iris Brouwer 020-7150043
2 Globeside, Globeside Business Park
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