The Clinical Project Manager is a key operational role where you will act as the primary point of contact between OPIS and the client to provide customer-focused leadership.
You will  independently manage and lead global studies across different locations, from project inception through to close out activities and according to set timelines, quality and budget. You will also manage and coordinate cross functional teams and vendors to ensure the overall project delivery for the client.
This is a fully home based/remote role in the US.

Some of what you will do:

• Proactively manage and coordinate overall project activities (local and international) to ensure deliverables meet contractual requirements, timelines, and quality standards.
• Lead clinical project teams and conduct various study team meetings.
• Organize and prepare kick-off meetings, sponsor meetings, investigator meetings, and internal project meetings, ensuring accurate documentation.
• Provide efficient updates on study progress to sponsors and internal teams.
• Prepare feasibility questionnaires and manage site feasibility and qualification processes.
• Develop project plans, study-specific procedures, and tools.
• Manage investigational product and study materials.
• Collaborate effectively with regulatory and submission teams.
• Review and approve study documentation and reports.
• Ensure timely resolution of site issues and implementation of action plans.
• Manage administrative aspects, including budget oversight and vendor interactions.
• Support proposal development and client presentations.
• Conduct monitoring visits, if necessary.
• Collaborate in establishing and maintaining SOPs.
• Mentor junior staff and support onboarding activities.

Requirements:

• Degree in a scientific field.
• Minimum 2 years of experience as a Clinical Project Manager.
• Excellent knowledge of ICH-GCP, ISO1455, and clinical trial monitoring techniques.
• Ability to coordinate local and international projects and oversee CRAs.
• Strong leadership and resource management skills.
• Proficiency in English language.
• Ability to work independently under supervision.

If you're ready to take the next step in your clinical research career, apply now to join our dedicated team. Let's make a difference together!

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.

Please read the information notice on the processing of personal data in the candidates information section of our company website.

Who we are:

OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.

OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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