Ref #: 36631
Employment type: Permanent - Full-Time
Location: Home based in Europe
Posted: 24-Jun-2022
Description
Roles & Responsibilities of the position:
The Global Trial Leader (GTL) provides global operational leadership for the cross-functional delivery of
assigned trial(s), within agreed timelines and budget and in alignment with all applicable SOPs and regulatory
requirements, in alignment with the organizational and therapeutic area (TA) Clinical Team (CT)’s objectives.
Services/deliverables include the global accountability and operational oversight of both internally managed
and outsourced trials, covering the end to end project management including start-up, execution, close-out,
analysis and reporting. The GTL is responsible for leading the cross-functional Trial Team and partners with
all trial team members, building the trial operational plan and is responsible for External Service providers’
(ESP) contracts and budget. The GTL has an operational leadership role in a matrix structure, while scientific
leadership is provided by the Study Responsible Physician. This includes coordinating activities in the trial
team and ensuring ad-hoc Working groups are organized as needed, driving issue identification and
resolution, contingency planning and decision-making.
Key Responsibilities:
• Leads the cross-functional Trial Team; tracking of project deliverables and timelines. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through.
• Accountable for delivery of global trials within agreed/projected life of trial budget
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines.
• Develops the trial ESP strategy for assigned trial(s) in line with the overall program ESP strategy.
• Is accountable for oversight of all external service providers for both inhouse and outsourced studies.
• Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP).
• Ensures transparent status reporting information to relevant key stake holders
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team
• Partners closely with the team members from Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners,
Job Requirements:
• Bachelor’s degree or equivalent, preferably in Life Sciences.
• Clinical trial experience in the pharmaceutical industry or CRO.
• Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills
• Experienced and proven track record of success in managing or leading global or regional teams in a virtual environment is required
• Strong expertise in vendor management.
• 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 with mentoring/coaching others.
What is offered:
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• 100% Home based
• Permanent contract
• Great work atmosphere
• Compensatory time-off
• Contribution to pension scheme
#pmjob
The Global Trial Leader (GTL) provides global operational leadership for the cross-functional delivery of
assigned trial(s), within agreed timelines and budget and in alignment with all applicable SOPs and regulatory
requirements, in alignment with the organizational and therapeutic area (TA) Clinical Team (CT)’s objectives.
Services/deliverables include the global accountability and operational oversight of both internally managed
and outsourced trials, covering the end to end project management including start-up, execution, close-out,
analysis and reporting. The GTL is responsible for leading the cross-functional Trial Team and partners with
all trial team members, building the trial operational plan and is responsible for External Service providers’
(ESP) contracts and budget. The GTL has an operational leadership role in a matrix structure, while scientific
leadership is provided by the Study Responsible Physician. This includes coordinating activities in the trial
team and ensuring ad-hoc Working groups are organized as needed, driving issue identification and
resolution, contingency planning and decision-making.
Key Responsibilities:
• Leads the cross-functional Trial Team; tracking of project deliverables and timelines. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through.
• Accountable for delivery of global trials within agreed/projected life of trial budget
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines.
• Develops the trial ESP strategy for assigned trial(s) in line with the overall program ESP strategy.
• Is accountable for oversight of all external service providers for both inhouse and outsourced studies.
• Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP).
• Ensures transparent status reporting information to relevant key stake holders
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team
• Partners closely with the team members from Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners,
Job Requirements:
• Bachelor’s degree or equivalent, preferably in Life Sciences.
• Clinical trial experience in the pharmaceutical industry or CRO.
• Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills
• Experienced and proven track record of success in managing or leading global or regional teams in a virtual environment is required
• Strong expertise in vendor management.
• 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 with mentoring/coaching others.
What is offered:
• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• 100% Home based
• Permanent contract
• Great work atmosphere
• Compensatory time-off
• Contribution to pension scheme
#pmjob