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The GCDO Trial Leader (GTL) has primary global accountability at the trial level within the GCDO organization.
What you will be doing:
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.
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.
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. 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 timelines. Responsible to drive the final study placement, and ensure alignment with and communication to the involved stakeholders, including TA and RTAEs.
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 in-house and outsourced studies. Is responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated 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 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 Quality Management & Compliance liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP), the GTL ensures appropriate trial-specific training is given to Trial Team members or to the CRO. Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
Responsible to ensure 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 and if they can not be resolved within the function and/or Trial Team they are escalated to the GCDO Program Leader (GPL) and Clinical Team level, as necessary. Manages timely and accurate documentation of issue escalation. Accountable to drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.
Strong interaction with the Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
What you need to have:
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
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.
To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.