Clinical Research Associate II / Senior / Principal – Renal, Transplant, Nephrology
Thermo Fisher Scientific
Google Cloud Platform
Study Start-up Project Manager
Biogen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $138,000 - $185,000 per year
Job Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Lead the strategy and execution of site activation activities 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
- Manage cross-functional collaboration and resource allocation to support study start-up
- Lead departmental growth initiatives and champion adoption of SSU process improvement tools and templates
- Harmonize processes and provide start-up expertise to assigned studies and programs, ensuring Final Protocol to First Patient In timelines are met or exceeded
Requirements
- B.A. or B.S. in a scientific discipline; advanced degree preferred
- 10+ years in Clinical Research with 5+ years in global clinical trial start-up
- Previous experience in a CRO essential, preferably in a senior start-up role leading cross-functional teams and managing global SSU deliverables
- Scientifically and clinically astute with very strong project management skills; skilled in planning, tracking milestones, and risk mitigation
- Deep understanding of ICH-GCP, global and local regulatory requirements
- Experience with IRB/EC submissions
- Ability to lead and influence in a matrix environment and take ownership of timelines and deliverables
- Proactive mindset with ability to identify bottlenecks and propose solutions
- Good organizational, time management, communication, and interpersonal skills
- Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
- Occasional travel required
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
- Regular employees eligible for short-term and long-term incentives, including cash bonus and equity opportunities
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchproject managementrisk mitigationsite activationregulatory submissionsmetrics analysisKPI monitoringprocess improvementcross-functional collaborationtimelines management
Soft skills
leadershipcommunicationorganizational skillsinterpersonal skillsproactive mindsetinfluence in matrix environmentownership of deliverablesproblem-solvingtime managementteam management
