Project Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee, manage, and coordinate the operational execution of Non-Amgen Sponsored Clinical Research (NASCR) from the point of submission receipt to project close-out.

• Supervise one or more ISS product portfolios, encompassing multi-regional studies.

• Direct NASCR initiatives in alignment with global ISS and EA Standard Operating Procedures (SOPs).

• Coordinate the review and endorsement of ISS proposals and protocols alongside cross-functional teams and governance entities.

• Serve as a liaison between the Sponsor and cross-functional teams to streamline ISS activities from the receipt of proposals to project close-out.

• Enhance sponsor communication and guarantee the quality and thoroughness of the entire NASCR process.

• Ensure the execution of Confidential Disclosure Agreements and completion of sponsor qualification processes.

• Support cross-functional evaluations of proposals, protocols, and amendments.

• Organize or assist with internal and sponsor meetings, including the preparation of agendas and minutes.

• Assure Fair Market Value assessments for funded ISS projects.

• Manage the submission of protocols, study packages, contracts, regulatory documents, and essential paperwork.

• Collaborate with Supply Chain representatives regarding investigational product supply, temperature excursions, and product complaints.

• Ensure the completion and re-evaluation of ISS Regulatory Assessment and Initiation Package documents.

• Update source systems, including tracking milestones and enrollment status.

⛳️ Requirements

• Legal authorization to work in the country where the position is located.

• Proven experience in managing and overseeing one or more ISS product portfolios, including multi-regional studies.

• Familiarity with global Investigator Sponsored Studies (ISS) and Expanded Access (EA) SOPs and related documentation.

• Experience in coordinating the review and approval of proposals and protocols with cross-functional teams and governance entities.

• Background in facilitating sponsor and cross-functional team activities from proposal receipt to project close-out.

• Knowledge of Confidential Disclosure Agreements, sponsor qualification, contracts, regulatory and quality documentation, supply chain coordination, and essential document management.

• Capability to facilitate internal and sponsor meetings, including the preparation of agendas and minutes.

• Proficient in conducting Fair Market Value assessments for funded ISS initiatives.

• Ability to maintain milestone tracking, enrollment status, archiving, and reconciliation of essential documentation.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.