Company: Docs Global (Continental Europe)
Reference: Ref AS-020098
Closing Date: 27 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
For more information please contact: Iris Brouwer firstname.lastname@example.org 06-51129787
Roles & Responsibilities of the position
The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)’s objectives. The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.
The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
Minimum of 8-10 years clinical trial experience in the pharmaceutical industry or CRO.
• Willingness and ability to travel up to 15-20% of the time, defined by business needs.
• Requires clinical research operational knowledge, project planning/management, communication and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing or leading global or regional teams in a virtual environment is required. Strong expertise in vendor management required.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operates and executes with limited supervision. Experience mentoring/coaching others. Ability to support and participate in the hiring, training, development and evaluation of staff on a regular basis.
• Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
The GCDO Trial Leader (GTL) has primary global accountability at the trial level within the GCDO organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.
2 Globeside, Globeside Business Park
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