Jobs in Massachusetts 2026 (Now Hiring) - Smart Auto Apply

POSITION SUMMARY

PRIMARY RESPONSIBILITIES

• Assist in overall management of clinical trials, including but not limited to managing study timelines and budgets as well as providing CRO and other external vendor oversight
• Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, study plans, lab manuals, Case Report Forms, Clinical Study Reports, and other study level documents
• Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
• Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Serve as a point of contact for CRO and clinical site communication
• Assist in the set up the Trial Master File (TMF) and ensure appropriate TMF maintenance throughout the trial, including periodic reviews
• Lead internal study team calls and ensure appropriate cross functional follow up and resolution to tasks in a timely manner
• Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
• Proactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts

QUALIFICATIONS

• Bachelor’s degree, life science or medical background preferred
• 7+ years work experience in life sciences or medically related field, including 4+ years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail with ability to flex communication style to all areas of the organization
• Working knowledge of Good Clinical Practices (GCP) and other relevant regulatory requirements
• Ability to travel up to 10% of the time
• Ability to be onsite in the Cambridge office 2 days per week