ARTBIO

Senior Clinical Trial Manager

Cambridge, MA · Senior

Sponsorship not specifiedDetected 89 days ago

ExpressGCPRESTComputer VisionClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunication

About the role

Our team works tirelessly to bring therapies that matter to patients who need them.
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.
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.

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.
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.

The successful candidate must be comfortable working independently and cross-functionally to ensure study compliance and data quality.
Provide financial and management accountability updates to internal stakeholders as required.
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).
Experience with clinical data review and data management processes.

Channeling Energy.
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.
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.
Changing Lives.
ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials.
Cancer is relentless.
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.

years of experience in clinical operations or direct study management in a biotech or pharmaceutical company (Industry Sponsor)

This listing is sourced directly from ARTBIO's careers page and normalized into a canonical job model.