Clinical Trial Manager

ARTBIO • Cambridge, MA

5d

About The Position

The Clinical Trial Manager plays an essential role in all aspects of clinical trial execution and management in a highly collaborative environment. The successful candidate will deliver on the operational needs of the role while bringing a thoughtful perspective, drive for results, and ability to work with, influence, and communicate with a variety of stakeholders. The successful candidate must be comfortable working independently, managing interactions with internal and external team members, and enthusiastic about learning new tasks outside the traditional clinical PM/CRA role to ensure that the clinical trials are managed to the highest quality to ensure the safety and effectiveness of ARTBIO’s products.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 3–5 years of experience in clinical operations in a biotech or pharmaceutical company (Industry Sponsor).
• Experience managing US clinical sites, including start-up activities and monitoring.
• Experience in oncology (preferably in solid tumors) or nuclear medicine; radiopharmaceuticals a plus.
• Experience overseeing CROs and vendors a plus.
• Familiarity with clinical data review and data management processes.
• Excellent communication, organizational, and leadership skills.
• Ability to work independently and manage multiple priorities.
• Excellent knowledge of GCP, ICH, and FDA regulations.

Responsibilities

• Support the implementation of clinical research studies within budget and on schedule.
• 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.
• Coordinate and support study team meetings in collaboration with the Clinical Development, Clinical Operations, Data Management, Clinical Supply Chain. and Clinical Quality team.
• Update the clinical team on timelines and milestones achieved for the study.
• Manage and mitigate risks with the study team.
• Provide Sponsor oversight of CROs and vendors in partnership with the rest of the Clinical Operations team to assure 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, such as onsite or remote monitoring, co-monitoring, and training visits, as needed
• Ensure that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Contribute to the development of study documentation, including protocol review, creating study operations manuals, ICFs, and designing CRFs.
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• 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.
• Train team members, site staff, and vendors, as needed
• Limited travel possible to clinical sites to supervise and/or monitor clinical studies (~25%).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level