Clinical Development Scientist
$203,710–$305,564 year
On-siteBoston, Massachusetts, United States or New Haven, Connecticut, United States
Job Summary
Conduct protocol and study document leadership by developing clinical study protocols, operations manuals, and monitoring plans to ensure efficient, inspection-ready execution. Monitor safety and efficacy data continuously, escalating emerging concerns to protect participants and timelines while investigating protocol deviations to identify root causes and implement mitigations. Leverage Medidata Rave and Elluminate tools to detect dataset inconsistencies, drive corrective actions, and resolve issues with CRAs and CROs to maintain high-quality trial conduct. Collaborate proactively with internal teams, site staff, and investigators to align evidence generation with program strategy and regulatory needs. Support due diligence for research collaborations and maintain awareness of scientific and regulatory developments impacting the development plan.
Required Qualifications
- Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree required)
- 2+ years of experience in designing and executing clinical trials
- Knowledge in the principles of literature search, clinical research methodology, statistics, data analysis and interpretation
- Ability to communicate clearly to internal and external stakeholders
- Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists and/or scientists
- Minimum of three days per week from the office
- Boston, MA or New Haven, CT
Desired Qualifications
- Advanced knowledge of the therapeutic area (Rare Disease Cardiology & Amyloidosis)
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