Clinical Trial Manager

Summary   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.

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%).

Qualifications & Education

• 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.

About Us Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.   The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.   Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work.      EEO Stat