Study Start UP Oversight Lead

Biogen

1d•$134,000 - $179,000

About The Position

This role is part of the Clinical Trial Accelerator Unit (CTAU) and is responsible for accelerating Study Start Up activities and ensuring all site activations are made on time in global clinical studies. The individual will harmonize processes and provide start-up expertise to assigned studies and programs, ensuring study teams meet or exceed Final Protocol to First Patient In timelines. The role involves direction and execution, quality compliance, risk management, performance monitoring and cross-functional collaboration. You are a subject matter expert with deep expertise in clinical research and study start-up. You thrive in fast-paced environments and excel at managing timelines, mitigating risks, and driving process improvements.

Requirements

B.A. or B.S. in a scientific discipline; advanced degree preferred
10+ years in Clinical Research with 5+ years in global start-up
Previous experience in a CRO preferred.
Scientifically and clinically astute with very strong project management skills and skilled in planning, tracking milestones, and risk mitigation
Ability to lead and influence in a matrix environment - takes ownership of timelines and deliverables
Proactive mindset with ability to identify bottlenecks and propose solutions
Good organizational, time management, communication, and interpersonal skills
A commitment to maintaining high standards of quality and compliance in all project-related activities
Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
Deep understanding of ICH-GCP, global and local regulatory requirements
Strong technical skills, familiarity with translation management systems
Occasional travel required

Nice To Haves

Experience with IRB/EC submissions

Responsibilities

Lead and oversee the execution of site activation for global clinical studies
Develop and maintain critical path and timelines for site activation
Oversee and negotiate timelines for Master Informed Consent Forms (ICFs), including country and site-level ICF creation.
Ensure site activation activities are inspection-ready and compliant with ICH-GCP and Biogen SOPs
Perform or delegate quality checks on submission and site essential documents
Ensure timely and accurate submissions to ethics committees and regulatory authorities
Conduct proactive risk assessments and guide mitigation planning
Analyze metrics and KPIs to monitor performance and drive improvement
Take part in departmental growth initiatives and champion adoption of SSU process improvement tools and templates
Managing relationships with some of our key start up vendors which could include language services providers, translation vendors and printing vendors

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation