Project Director

Empresa: PRA Health Sciences
Tipo de trabalho: Tempo integral

The Global 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.
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 Project Director/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.
Responsibilities:
* 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 inhouse 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 primairy 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 stakeholders
* 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.
Qualifications:
* 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.
PRA is an EEO/AA employer and is committed to providing opportunities to
minorities, women, veterans and individuals with disabilities.

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