Senior Clinical Trial Associate
$90,000–$100,000 year
On-siteBurlington, Massachusetts, United States
Job Summary
Manage day-to-day operational planning and execution for Global Phase 1-3 clinical studies, including start-up, conduct, and close-out activities. Coordinate study documents, vendor activities, and quality reviews while supporting site start-up and monitoring. Contribute to developing study-related documents such as protocols, informed consents, and patient recruitment materials. Prepare study dashboards and metrics reports to support management oversight and decision-making. Assist in vendor oversight, analyze operational trends, and recommend mitigation strategies for identified risks. Lead reviews of trial operational deliverables, including monitoring reports and Trial Master File status checks. Mentor and onboard Clinical Trial Associates by providing training on departmental processes and best practices.
Required Qualifications
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
- Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
- Must have excellent interpersonal, written and verbal communication skills
- Skilled in developing collaborative internal and external relationships
- Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- Relevant scientific or health related field Bachelor's degree
- At least 3 years of relevant work experience in a pharmaceutical or biotechnology or CRO environment
- Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
- Experience in managing CROs and external vendors
- Some travel may be expected for this position including internal meetings, conferences or training events
- This role is required to be onsite in Burlington office 3 days a week
Desired Qualifications
- Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus; Experience in use of AI tools (Claude)
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