Über diese Senior Clinical Trial Manager Stelle bei Artbio

Artbio · Vor Ort · Cambridge, MA

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.

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 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.

Questions and Application Process

If interested, please apply and send your CV to HR@artbio.com. All inquiries are treated confidentially.

ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.

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Über diese Senior Clinical Trial Manager Stelle bei Artbio

Summary

Responsibilities

Qualifications & Education

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