We're looking for a seasoned Senior Clinical Project Manager to lead the charge on local and international projects. You'll be the bridge between ambitious study goals and flawless execution, ensuring every deliverable—from the first feasibility questionnaire to the final TMF archival—hits the mark. If you're a natural leader who thrives on complexity and can navigate the nuances of global regulations, let's talk.
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As a Senior CPM, you are the conductor of the clinical trial orchestra. You'll manage the full lifecycle of local and international projects, ensuring they stay on track, on budget, and in total compliance with ICH-GCP and ISO14155 standards. You won't just manage tasks; you'll lead an internal study team, mentor junior staff, and act as the primary point of contact for Sponsors and Vendors.
What You'll Do:
Lead & Coordinate: Spearhead the clinical project team, leading everything from kick-off meetings to bid defense presentations.
Strategic Oversight: Develop project plans, manage trial timelines, and forecast resource needs (units/hours) to ensure contract adherence.
Operational Excellence: Oversee IMP/MD supplies, manage vendor quality, and collaborate with Regulatory teams to fast-track submissions and site contracts
Quality Control: Review site reports, oversee the Trial Master File (TMF) to ensure it's audit-ready, and perform co-monitoring visits when necessary.
Risk Management: Proactively identify potential bottlenecks, implement solution-driven action plans, and escalate risks before they become issues.
Financial Stewardship: Manage study budgets, track billable hours via internal systems, and interface with Finance for extra-budgetary needs.
What You Bring:
Education: A Degree in a scientific field.
Experience: At least 7 years of proven experience as a Clinical Project Manager.
Technical Mastery: Deep knowledge of ICH-GCP and ISO14155 (for medical devices).
Leadership: A track record of overseeing CRAs and managing multi-disciplinary, international teams.
Communication: Excellent English skills (written and verbal) and the ability to present confidently to Sponsors and stakeholders.
Autonomy: The ability to work independently while keeping the Clinical Operations Manager in the loop.
What we offer:
We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.
At OPIS, you'll join a collaborative international team where initiative and growth are encouraged.
If you're ready to build your career in business development within the clinical research industry — we'd love to hear from you!
Who we are:
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. xiphteb
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients' challenging achievements.