Description
As a Project Manager at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will be responsible for leading and coordinating project activities, ensuring that global trials are delivered on time, within budget, and to the highest quality standards.
Responsibilities:
- Supporting the execution of select studies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
- Accountable for planning and operational execution for specific tasks within assigned clinical trials.
- Oversight of Strategic Partners - CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner for assigned studies.
- Ensure studies are 'inspection ready' at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
- Support data review for database lock and CSR writing and review (including appendices).
- Collect/review/File study documents in support of the trial master file (TMF).
Requirements:
- 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management oversight.
- Proven track record of successfully managing projects, with a focus on delivering results within scope, time, and budget constraints.
- Experienced in vendor selection and oversight.
- Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks.
- Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations.
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
- Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous.
- Fluent business English (oral and written).
Rewards & 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.