Remote Senior Clinical Program Manager – IIS & EAP

Sigma Systems, Inc.; Marlborough (MA); Remote; USD 120,000 - 150,000; Full time

Job summary

Sigma Systems, Inc. seeks a Senior Clinical Project Manager for a 7-month contract to oversee IIS, Collaborative Research and Expanded Access Programs.

You will coordinate with Medical Affairs, Clinical Operations, R&D, and other functions to ensure study execution from planning through closeout. The role requires strong project management, oncology knowledge and a proven ability to manage budgets, contracts and timelines across cross-functional teams, including investigators and external

Qualifications

• BS./MS./Ph.D. in a related life science discipline is preferred.
• Thorough understanding of the oncology arena.
• Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.

Responsibilities

• Oversee Investigator Initiated Studies (IIS), Collaborative Research and Expanded Access Programs.
• Provide operational oversight of IIS, Collaborative Research, and EAP portfolio including planning, execution, monitoring and closeout.
• Lead cross-functional collaboration with Medical Affairs, Clinical Operations, R&D, Supply, Pharmacovigilance, Regulatory, Legal, Finance and other functions.
• Monitor study progress, milestones, enrollment, timelines, drug accountability and contractual obligations.
• Identify risks and develop mitigation/contingency plans with minimal oversight.

Skills

Leadership

Cross-functional collaboration

Project management

Oncology knowledge

Clinical trials understanding

Education

BS/MS/PhD in life sciences

Job description

Sigma Systems, Inc. seeks a Senior Clinical Project Manager for a 7-month contract to oversee IIS, Collaborative Research and Expanded Access Programs.

You will coordinate with Medical Affairs, Clinical Operations, R&D, and other functions to ensure study execution from planning through closeout. The role requires strong project management, oncology knowledge and a proven ability to manage budgets, contracts and timelines across cross-functional teams, including investigators and external