Clinical Study Manager

ICON plc • Blue Bell, SD

6d

About The Position

At ICON Strategic Solutions, the Clinical Study Manager works in a sponsor-dedicated model, exclusively supporting one pharmaceutical company while benefiting from ICON’s global expertise. The role focuses on supporting operational delivery in close collaboration with the Global Trial Study Leader and coordinating project activities to help ensure global trials are delivered on time, within budget, and to high quality standards. The position includes study execution and oversight, vendor and strategic partner management, inspection readiness, and support for study documentation, data review, and regulatory filings.

Requirements

• At least 5 years of experience in the pharmaceutical industry and/or a clinical research organization.
• At least 3 years of clinical study management oversight experience, including significant study management support experience such as clinical trial assistant/associate or lead CRA.
• Experience may include early-phase clinical studies or Phase 2 and 3 studies, and global/international studies or programs.
• Proven track record of managing projects and delivering results within scope, time, and budget constraints.
• Experience in vendor selection and oversight.
• Strong leadership and organizational skills, including the ability to manage project teams and prioritize tasks.
• Excellent communication and interpersonal skills, including the ability to build relationships and manage stakeholder expectations.
• Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP; awareness of local country requirements may also be required.
• Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement.
• Fluent business English, spoken and written.
• Legal right to work in the country where the role is based.

Nice To Haves

• Experience in more than one therapeutic area.
• Project management certifications such as PMP or PRINCE2.

Responsibilities

• Support execution of assigned studies in compliance with quality standards, including ICH GCP, local regulations, and SOPs, and in accordance with schedule and budget.
• Plan and oversee operational execution of specific tasks within assigned clinical trials; coordinate with functional leads to support milestone delivery and project objectives.
• Oversee strategic partners, including CRO/vendor selection, budget and contract negotiation, and performance supervision; escalate issues to governance committees when warranted.
• Review and approve key monitoring documents and plans, and periodically review monitoring outputs, decisions, and actions.
• Conduct Oversight Monitoring Visits, as applicable.
• Review and endorse relevant study plans, as applicable.
• Manage and attend study team meetings when necessary, and regularly review meeting agendas and minutes.
• Review outcomes and actions related to protocol deviation reviews to help identify trends across sites or the study.
• Document review and monitoring of study-level issues, risks, and decisions, and implement appropriate mitigation strategies.
• Review and own trial operational data, such as CTMS data.
• Review and provide oversight of internal trial reports.
• Keep studies inspection-ready and support regulatory inspections through preparation and/or attendance.
• Prepare for agency inspections, including document readiness, tracking, storyboard development, and other relevant materials and preparations.
• Support data review for database lock and CSR writing and review, including appendices.
• Collect, review, and file study documents in support of the trial master file (TMF).
• Collect, review, and file study documents in support of regulatory filing.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed