Global Trial Delivery Lead - Sponsor Dedicated

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f0jrn

The
Trial Delivery Leader (TDL)
serves as the
single point of accountability
for
trial operational strategy, trial-level budget, quality, and on-time delivery
of assigned clinical trials. This role represents the
evolution of the Global Trial Leader (GTL)
, with a stronger emphasis on strategic leadership, end-to-end accountability, and governance-level decision making.
The TDL works in close partnership with the
Program Delivery Leader (PDL)
and co-leads the
Cross-Functional Trial Team (CFTT)
to ensure trial strategies are aligned with program objectives and executed efficiently.
The Trial Delivery Leader plays a
critical role in ensuring clinical trials are delivered efficiently, compliantly, and with high quality
, while balancing speed, cost, and innovation. By serving as the single point of accountability, the TDL enables clearer decision making, stronger execution, and improved trial outcomes across the development portfolio
Scope of Focus
The Trial Delivery Leader is primarily focused on
strategic leadership and execution oversight
, rather than administrative task execution. Key focus areas include:
Co-leading the CFTT and driving cross-functional alignment
Coordinating functional strategies (e.g., trial endpoints, ARBM, biomarkers, DEICT, digital health, companion diagnostics)
Ensuring timely delivery of
trial-level deliverables
Trial-level
budget ownership and oversight
Quality oversight and inspection readiness
Early operational input during
initial protocol development
Development of
cost-optimized and accelerated scenarios
and innovative approaches, aligned with trial tiering (post-POC)
Key Accountabilities
Develop the
trial operational strategy
, integrating and aligning all
trial-level functional strategies
into a single, holistic approach, including vendor strategy.
Partner closely with the
PDL
to shape trial-level strategy in alignment with overall program strategy.
Co-lead the
Cross-Functional Trial Team (CFTT)
, setting meeting cadence, agendas, and expectations.
Empower CFTT members to independently drive their functional deliverables while maintaining accountability for timelines and quality.
Serve as the
single point of accountability
for
on-time delivery, quality, and trial-level budget
across assigned trials.
Ensure all
trial milestones, quality targets, and budget commitments
are met.
Provide
budget management and oversight
at the trial level, including scenario planning and cost optimization.
Review and approve key
study-level documents
(e.g., global master ICFs).
Proactively identify, assess,



and mitigate
trial-level risks
, overseeing them through to closure.
Define
protocol deviation and resolution pathways
.
Take ownership of
study-level escalations
, including vendor performance issues and enrollment risks.
Communicate trial risks, issues, changes, and milestones to relevant stakeholders in a timely and transparent manner.
Represent
Global Development (GD)
at
trial-level therapeutic area (TA) governance forums
.
Contribute to and influence
governance decisions
, ensuring operational feasibility and alignment.
Attend
Clinical Team (CT) meetings
when requested by the PDL.
Ensure strong alignment with key stakeholders on
protocol amendments, enrollment targets, and study changes
.
Ensure all
trial operational activities, TMF, and study documentation
are
health authority–compliant
, inspection-ready, and meet required quality standards at all times.
Set up and oversee
clinical trial systems and documentation
, including (but not limited to): E7 drivers, Safety Management Plan, JJAR & Unified Clinical Trial Team (UCT) setup
Candidate Profile – Requirements
Bachelor's degree (BS) or equivalent in
Life Sciences
(e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
6–8 years of clinical trial management experience
within the pharmaceutical industry or a CRO, including specific therapeutic area experience
Proven experience managing clinical trials
end to end
, from
start-up through database lock and trial close-out
Strong working knowledge of
ICH-GCP
, local laws, and regulatory requirements
Superior
clinical research operational knowledge
with a demonstrated track record of delivery
Ability to ensure ongoing
quality, compliance, and inspection readiness
Demonstrated
effective leadership
, with the ability to proactively guide study teams through key trial stages
Proven ability to
delegate effectively
while maintaining accountability
Experience leading teams from
formation to high-performance
Strong capability to manage
multiple global stakeholders
and cross-functional partners
Proven experience coordinating
global or regional teams in a virtual environment
, for a minimum of




2 years (preferably 3+)
Ability to foster team productivity, alignment, and cohesiveness across geographies
Strong
project planning and project management
capabilities
Proven experience in
proactive planning
, risk identification, and mitigation throughout the trial lifecycle
Ability to gain
team consensus on updated plans
during changing project circumstances
Demonstrated capacity for
independent, complex decision making
Solution-oriented mindset with strong problem-solving skills
Strong IT skills, including proficiency with
Microsoft applications
and familiarity with: Trial Master File (TMF) & Iinical Trial Management Systems (CTMS)
Willingness and ability to learn new systems and technologies
Monitoring experience
is recommended; other relevant experience (e.g., data management or central monitoring) will be considered
Excellent
verbal and written communication skills
, supporting effective collaboration
Proven experience developing
presentations
and presenting complex information to stakeholders
Strong
analytical skills
, with the ability to manage ambiguity when limited information is available
Ability to understand, plan, and oversee
country- and vendor-level budgets
Awareness of
country Out-of-Pocket (OOP) cost drivers
and FTE-related cost components
Willingness to
travel
, as required
Proficiency in
English
(spoken and written) and the
local country language
, as applicable
*Please note This role is not eligible for UK visa sponsorship
Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f0jrn