Senior Clinical Project Lead: IIS & EAP (Remote)

Sunrise Systems, Inc.; Massachusetts; Hybrid; USD 72.000 - 79.000; Vollzeit

Benefits dieser Stelle

Medical/dental/vision insurance

Sick time benefits

Zusammenfassung

Sunrise Systems, Inc. is seeking a Senior Clinical Project Manager to oversee Investigator-Initiated Studies, Collaborative Research, and Expanded Access programs in Marlborough, MA with remote options.

You will lead cross-functional teams across Medical Affairs, Clinical Operations, Regulatory, and Legal to plan, execute, monitor and close studies, while managing budgets, timelines, and study deliverables in a fast-paced environment.

Qualifikationen

• Proven leadership and executive presence with strong written/oral communication.
• Experience in matrix environments and working with investigators, CROs, and external partners.
• Ability to coordinate across Medical Affairs, Clinical Operations, Regulatory, Legal, Finance, and other functions.
• Strong attention to detail, prioritization, and meeting deadlines.
• Familiarity with design and conduct of clinical trials and regulatory requirements.
• Data-driven analytical approach to planning and problem solving.

Aufgaben

• Oversee IIS, Collaborative Research, and Expanded Access programs from planning to closeout.
• Lead cross-functional collaboration to support study execution.
• Act as operational contact for investigators and external partners.
• Monitor milestones, enrollment, timelines, and deliverables.
• Identify risks and develop mitigation plans with minimal oversight.
• Negotiate and finalize Clinical Trial Agreements and study budgets.
• Monitor study budgets, milestones, and payments.
• Prepare study documents and ensure proper documentation.

Kenntnisse

Leadership

Cross-functional teamwork

Project management

Regulatory knowledge

Budget management

Stakeholder communication

Ausbildung

Life sciences degree (BS/MS/PhD)

Jobbeschreibung

Sunrise Systems, Inc. is seeking a Senior Clinical Project Manager to oversee Investigator-Initiated Studies, Collaborative Research, and Expanded Access programs in Marlborough, MA with remote options.

You will lead cross-functional teams across Medical Affairs, Clinical Operations, Regulatory, and Legal to plan, execute, monitor and close studies, while managing budgets, timelines, and study deliverables in a fast-paced environment.