Key skills
Google Cloud PlatformGCPGoogle CloudProject ManagementCommunication
About this role
Role Overview
- Responsible for clinical trial management of multiple studies
- Oversee/leads study-specific study management resources
- Mentor other Clinical Project Managers
- Serve as the project lead for multiple studies of high complexity
- Prepare and/or review study-related or essential study start-up documents
- Ensure that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team
- Develops and manages group of studies for an entire business unit or large development program
- Handle relationships with sites/PIs and vendors, including CROs
- Define, track and report schedule attributes such as durations, interdependencies, and key deliverables
- Proactively identify and manage risks and issues to ensure cost-effective and timely delivery of the project
Requirements
- Bachelor's degree, preferably in the life sciences, clinical or other relevant technical areas.
- Minimum of 5 years of clinical study experience (pharmaceutical, medical device, IVD, biotechnology, or CRO).
- Proven ability to lead cross‑functional clinical teams in the planning, execution, oversight, and reporting of complex, global, multicenter studies—from initiation through closeout.
- Minimum of 5 years project management experience, preferably using MS Project.
- Strong knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulatory requirements.
- Hands‑on experience managing the Trial Master File (TMF), ensuring accuracy, completeness, timeliness, and ongoing inspection‑readiness in compliance with ICH‑GCP and regulatory standards.
- Proven ability to influence cross-functional teams without formal authority.
- Proven successful project management skills with meticulous attention to detail.
- Strong client and vendor relationship management skills.
- Exceptional written and verbal communication skills.
- Expert-level knowledge of clinical operations procedures.
- Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP).
Tech Stack
- Google Cloud Platform
Benefits
- Annual Bonus and Potential Discretionary LTI Bonus
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave