Associate Director, Global Trial Leader - Home Based
Company: PRA Health Sciences
Posted on: June 12, 2021
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Who are we?
We Are PRA.
We are 20,000 employees strong, operating in more than 90
countries. We are committed to saving lives and we are constantly
striving to be the best at what we do. Our impact is real and we
see it every single day. We are getting life saving drugs into the
hands of those who need them most.
Who are you?
You are a leader that isn't afraid to delegate, but also isn't
afraid to get your hands dirty. You look for new and innovative
ways to problem solve. You are the ultimate planner and coordinator
and are an excellent communicator. You have a serious passion for
clinical development. You never settle for what is, but are always
pushing clinical development forward to what it could be. You
motivate others to do the same. Most of all, you want to do it in a
place where you're more than an employee number. A place you love
Still here? Good. Because if this is you, we'd really like to
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,
- 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
- 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
- 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
- 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
- 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
- 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
Keywords: PRA Health Sciences, Eugene , Associate Director, Global Trial Leader - Home Based, Other , Remote, Oregon
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