Clinical Study Manager
13 hours ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Key Responsibilities:- Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
- Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level to ensure appropriate control over the vendor identification and selection.
- Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish the required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required.
- For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed-upon timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines.
- Develop and maintain relevant study plans (e.g., global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning.
- Oversee study level performance against agreed-upon plans, milestones, and key performance indicators (KPIs, quality, and operational) by using company tracking systems and project timelines and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.
- 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.
- University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research.
- Proven project management experience and training.
- Experience in CAR-T studies is required.
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; startup, maintenance, and close out.
- Strong abilities in establishing and maintaining effective working relationships with senior stakeholders, along with strong conflict management skills.
- Ability to manage multiple competing priorities.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
We are an equal opportunities employer and welcome applications from all qualified candidates. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
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