What You Will Do:

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study related meetings.
• Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
• Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
• Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
• The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
• Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
• Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
  

Your Profile:

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• 5 + years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial Management
• Experience overseeing large global clinical trial projects
• Experience overseeing Oncology studies/projects is required

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 to read more about the benefits ICON offers.