Senior Clinical Trial Manager

ARTBIO; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

ARTBIO is seeking a Senior Clinical Trial Manager to oversee the daily operations of clinical trials in Cambridge, Massachusetts. The ideal candidate will have 5 to 8 years of experience in clinical operations or study management within the biotech or pharmaceutical sectors. The role includes leading cross-functional teams, managing clinical sites, and ensuring compliance with GCP, ICH, and FDA regulations. Excellent communication and leadership skills are essential. Limited travel to clinical sites will be required.

Qualifications

• 5 to 8 years of experience in clinical operations or direct study management in a biotech or pharmaceutical company.
• Extensive experience managing US clinical sites, including start-up activities and monitoring.
• Strong working knowledge of GCP, ICH, and FDA regulations.

Responsibilities

• Lead cross-functional meetings to drive study activities.
• Manage Phase 1 and 2 clinical trial investigators to ensure compliance.
• Oversee CROs and vendors to assure data integrity.

Skills

Communication skills

Clinical operations management

Risk management

Leadership

Data management

Education

Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or related field

Job description

Summary

The Senior Clinical Trial Manager will lead the day-to-day activities in a clinical trial, and support the program strategy in a highly collaborative environment. The successful candidate will manage members of the clinical operations team, including those at CROs and study vendors, work collaboratively with clinical trial sites, and partner with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in line with regulatory requirements. The successful candidate must be comfortable working independently and cross-functionally to ensure study compliance and data quality.

Responsibilities

• Lead cross‑functional meetings with the Clinical Development, Clinical Operations, Data Management, regulatory, Quality, and Clinical Supply Chain.
• Support the development within budget and on schedule.
• Drive study startup activities, including feasibility, site selection, and timelines.
• Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance with the study protocol and overall clinical objectives.
• Maintain clear communication across all departments.
• Proactively manage, identify, and mitigate risks with the study team.
• Serve as cross‑functional lead for the clinical trial.
• Identify and report potential program issues and implement CAPAs where necessary.
• Act as the primary point of contact for trial execution and escalation.
• Provide financial and management accountability updates to internal stakeholders as required.
• Lead the oversight of CROs and vendors in partnership with the rest of the Clinical Operations team to assure the integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, medical records, etc.
• Perform clinical research site activities, which can include onsite or remote monitoring, co‑monitoring, and training visits.
• Ensure that all study documentation and SOPS are maintained according to applicable regulations and industry‑accepted standards, both in the field and in‑house.
• Contribute to the development of study documentation, including protocol review, study operations manuals, SOPs, ICFs, CRFs, CSRs, IBs, and data cleaning.
• Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
• Limited travel possible to clinical sites to supervise and/or monitor clinical studies (~25%).

Qualifications & Education

• Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• 5 to 8 years of experience in clinical operations or direct study management in a biotech or pharmaceutical company (Industry Sponsor).
• Excellent communication skills.
• Extensive experience managing US clinical sites, including start‑up activities and monitoring.
• Experience in oncology (preferably in solid tumors); radiopharmaceuticals a plus.
• Experience overseeing CROs and vendors, maintaining timelines, and overseeing budgets.
• Experience with clinical data review and data management processes.
• Excellent communication, organizational, and leadership skills.
• Ability to work independently, plan, prioritize, and risk mediate in a fast‑paced environment.
• Strong working knowledge of GCP, ICH, and FDA regulations.

EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.