DOCS Global

Global Trial Leader (AD Level) with Top Global Pharma/ Home-based/ Permanent

United Kingdom, UK
05 Feb 2021
07 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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.

• Leads the cross-functional Trial Team; tracking of project deliverables and timelines using functional planning tools and support. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
• 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 (OOP) costs and FTE costs. Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within agreed timelines. Responsible to drive the final study placement and ensures alignment with and communication to the involved stakeholders, including TA and feasibility leads.
• 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. Is responsible for vendor selection and set up, including scope of work and specifications in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated vendor issues are appropriately resolved. For outsourced trials is responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO. Is primary point of contact for the assigned Project Director/Manager from the CRO responsible for the trial.
• Ensures that the trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Bioresearch Quality and Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Ensures appropriate trial-specific training is provided to the trial team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
• Ensures transparent status reporting information to relevant key stake holders in Janssen R&D.
• Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they can't be resolved within the function and/or Trial Team they are escalated to the GPL and Clinical Team level, as necessary. Manages timely and accurate documentation of issue escalation. Drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.

Educations and experience:

• Bachelor's degree or equivalent, preferably in Life Sciences.
• 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Requires in-depth clinical research operational knowledge, strong project planning/management, communication and presentation skills.
Must have the ability to manage all aspects of execution of a clinical trial.
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 and CRO 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.

For more information contact: along with your CV.

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