Company: Docs Global (Continental Europe)
Reference: Ref AS-021588
Closing Date: 30 Apr 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Fantastic career opportunity Sr. Clinical Trial Manager for a major Pharma company
Roles & Responsibilities of the position
The position is responsible for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. Responsibilities also include management of global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. This position leads the Study Management Team (SMT) and interfaces with the Global Operations Support Teams, other Global Clinical Development Operations (GCDO) functions, Study Responsible Physician and Global Clinical Operations (GCO) or CRO/vendor staff and Study Sites (if applicable).
Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team (SMT). Support GTL in managing related CRO activities. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL.
- Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.
- Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.
- Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
- Create appropriate trial-specific training materials and requirements, making them available to the GCO site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration with GCO staff as well as GTL.
- Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Requires clinical research operational knowledge, strong project planning/management and excellent communication skills, Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven track record in successfully managing trials from start-up to database lock. Experience with supervision of CROs/vendors is preferred.
- Ability to operate with limited day to day supervision. Can act as a back-up to the GCDO Trial Leader. Coach and mentor junior staff as needed.
- Specific therapeutic area experience may be required depending on the position.
- Independent decision-making skills are essential to this role as are analytical skills and effectiveness in seeking solutions to issues.
- Effective leadership and delegation skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.
- Willing to travel up to 20% of time.
Attractive Salary + Benefits in a challenging environment
Please send your CV to firstname.lastname@example.org
For more information +32 (0)16 39 47 33
2 Globeside, Globeside Business Park
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