Senior Study Delivery Lead

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities. Your role will involve overseeing all aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.

What You Will Do:

Ideally, you will be a Project Manager or experienced Senior Clinical Trial Manager with retrospective and prospective designs, post authorization safety studies, real world evidence, and epidemiology experience. This is a leadership role, and you need to demonstrate global clinical study management experience in leading and driving cross-functional teams.

• This position combines end-to-end design, execution, and reporting of clinical studies and trials including:
• Non-interventional studies using primary data collection, including prospective studies enrolling patients and / or HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs / chart abstraction), patient reported outcomes development and validation.
• Global clinical study management experience across different countries and regions is essential to succeed in the role.
• Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence / incidence studies of exposure, risk factors and outcomes.
• Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients.
• Economic modelling studies and supplemental analyses of clinical trials / meta-analyses.
• Interventional and low-interventional studies.

This includes responsibility and / or accountability for the set-up, coordination, execution and delivery of studies in partnership with the Science Lead:

• Planning and leading the delivery of NIS to time, quality, budget, company standards and scientific requirements from concept protocol to final study report.
• Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports.
• Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms / tools etc).
• With the majority of NIS fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH / GCP & ENCePP guidelines and/or applicable guidelines for studies
• Make decisions which balance risk / benefit. Mitigate risk where appropriate.
• Work with matrix partners, Study Delivery Director and/or manager to develop and manage study level budget within project budget allocation.
• Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills.

The position may include:

• Leadership of a study team with single point accountability for delivery of the study
• Have primary responsibility and be a focal point of contact for interactions with key stakeholder groups including lead scientists (epidemiologists, health economists, health outcomes, etc.) data management, biostatistics, legal, compliance and project management.

Your Profile:

• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
• Demonstrated experience leading in matrix environment to deliver projects, develop clinical plans, and manage change.
• Ability to work independently and proactively and to take on leadership roles on cross-functional study teams.
• Excellent leadership, influencing and negotiation skills.
• Ability to lead and drive change, continuous improvement and learning, effectiveness at building networks of partners and stakeholders. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.

Required qualifications and experience:

• A minimum ideally of 6+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization.

·         Bachelor's degree in health, life sciences, or Advanced degree (e.g. MS, PhD, PharmD)

• Ideally, at least 10+ years of relevant experience in clinical trial management.
• Experience in managing complex or global trials is advantageous.
• Preferred: Experience in managing all trial components from start-up to database lock.
• Preferred: Experience in leading and driving cross-functional teams including oversight of external CROs, etc.
• Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply