Study Start Up Project Manager - Remote

Overview

This role is a member of the Clinical Trial Accelerator Unit (CTAU) taking broad responsibility for accelerating Study Start Up activities, harmonizing processes and providing start-up expertise to studies and programs to which they are assigned, to ensure study teams meet and exceed the Final Protocol to First Patient In timelines and ensure all sites in the study are activated on time.

In Short

• Oversight role in Study Start Up activities.
• Collaboration with Clinical Trial Lead (CTL).
• Ensure compliance with Biogen SOPs and regulations.
• Build MS Project plans for activities.
• Maintain study dashboard and monitor site activations.
• Involvement in feasibility, site selection, and contracting.
• Support special projects and develop templates.
• Proficient in MS Project and MS Excel.
• 5 years of clinical research experience required.
• Good organizational and communication skills.

Requirements

• B.A. or B.S. in a scientific discipline; advanced degree preferred.
• Strong project management skills.
• Knowledge of ICH-GCP and GMP/GDP.
• Experience with Veeva CTMS is ideal.
• 3 years of Study Start Up management experience.
• Prior CRO or investigator site experience is a plus.
• Good negotiation skills.
• Able to work in a matrix environment.

Benefits

• Medical, dental, and life insurance.
• Vacation and end-of-year shutdown.
• 401K participation and matching contributions.
• Participation in LTI grants and incentive programs.