Company: Docs Global (Continental Europe)
Reference: Ref AS-021366
Closing Date: 30 Apr 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
The Global Trial Leader has primary global accountability at the trial level within the organization. You will be 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.
Roles & Responsibilities of the position
Leads the cross-functional Trial Team; Tracking of Project Deliverables & Timelines using Functional Planning tools and support. Proactively manages that trial deliverables and milestones are met.
- Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both out of pocket costs and FTE costs.
- Ensures that environmental analysis, as applicable, protocol feasibility and country & site selection process is conducted within timelines.
- Develop the trial ESP strategy for his/her assigned trial in line with the overall program ESP strategy. Is accountable for oversight of all external service providers used for the trial for both inhouse and outsourced studies.
- Ensure Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
- Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents.
- Ensures Trial Team, SMT members, and the CRO, as applicable, have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP).
- Responsible to ensure transparent status reporting to relevant key stake holders.
- Ensures trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they cannot be resolved within the function and/or Trial Team they are escalated to the GCDO ED Program Leader ( ED GPL) and Clinical Team level, as necessary.
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
- Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO.
- Requires clinical research operational knowledge, project planning/management, communication and presentation skills.
- Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience in Late Development clinical trials.
- Willingness and ability to travel up to 15-20% of the time.
Looking for an exciting position in a global company? Do you want to know more.
Do not hesitate to contact Carine Louckx at firstname.lastname@example.org
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