About This Role:As a Clinical Trial Manager, you will be a vital part of the PO&T team within the Implantable Device Unit, supporting the planning, coordination, and execution of clinical studies. Your role is crucial in ensuring that trials are conducted efficiently and in compliance with regulations, driving valuable outcomes for the business.
Working closely with cross-functional partners, study sites, and external vendors, you will manage the day-to-day operations of clinical trials, tracking progress and identifying risks. By maintaining trial documentation and collaborating with diverse teams, you will help ensure high-quality data and participant safety. This position offers the opportunity to contribute significantly to the successful delivery of clinical trials under the leadership of the Director of Device Clinical.
This is a hybrid role to be based at our Headquarters in Cambridge, MA.
What You'll Do:- Support day-to-day clinical trial execution by tracking study activities and timelines.
- Collaborate with study sites, CROs, and external vendors to ensure trial conduct aligns with protocols and quality expectations.
- Monitor study progress and operational metrics, identifying and escalating risks or issues.
- Assist in vendor oversight and site management by reviewing performance and coordinating follow-up actions.
- Partner with internal stakeholders in Safety, Regulatory, and Quality to support consistent trial execution.
- Facilitate communication and action item follow-up with study sites and external vendors.
- Support the resolution of operational issues affecting study timelines or data quality.
- Prioritize study activities based on timelines, site needs, and agreed priorities.
- Coordinate routine communications and follow-up actions with study sites and vendors.
- Manage complex study execution issues involving multiple stakeholders and tight timelines.
- Organize and track study follow-up activities to ensure consistent execution across sites and vendors.
- Support management of vendor or site performance issues and coordinate communication to reduce impact on study execution.
Who You Are: You are an organized and detail-oriented individual with a deep understanding of clinical trial operations. Your proactive approach allows you to navigate complex situations and coordinate effective solutions. You thrive in collaborative environments and are adept at fostering partnerships with cross-functional teams, external vendors, and study sites. Your strong communication skills and ability to manage competing priorities make you an asset to any clinical trial team.
Required Skills:- Bachelor's degree and at least 5 years of experience in clinical research or clinical operations.
- Experience supporting studies of Class III implantable medical devices in a sponsor, CRO or clinical study site setting.
- Experience in vendor and site management.
- Strong organizational and communication skills.
- Ability to identify and resolve operational risks and issues.
- Knowledge of regulatory, safety, and quality protocols.
Preferred Skills:Job Level: Management
Additional InformationThe base compensation range for this role is: $117,000.00-$157,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Job Level: Management
