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Jobs at ARTBIO (Now Hiring) — 4 open

ARTBIO logoARTBIO

Senior Clinical Trial Manager

Cambridge, Massachusetts, United States · On-site

Senior$245M raised

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 t…

Skills: Clinical Trial Management, CRO Oversight, Study Startup, Site Monitoring, GCP

ARTBIO logoARTBIO

Office Coordinator (Temp Position, 12 months, 50-60%)

Oslo, Norway · On-site

Entry level$245M raised

Summary At ARTBIO, we are looking for a structured and service-minded Office Coordinator to support our Oslo office. This is a part-time role (approx. 50–60%) based on-site in Oslo. You will play a key role in creating a…

Skills: Office Coordination, Facility Management, Event Planning, Onboarding/Offboarding, Vendor Management

ARTBIO logoARTBIO

Associate Director, CMC Development

Oslo, Norway · On-site

Senior+$245M raised

Summary The Associate Director, CMC Development provides scientific and cross-functional leadership for radiopharmaceutical development programs spanning discovery through First-in-Human readiness. The role integrates ra…

Skills: Radiochemistry, CMC Development, Analytical Development, GMP Principles, Clinical Manufacturing

ARTBIO logoARTBIO

Senior Director, Clinical Operations

Cambridge, Massachusetts, United States · Hybrid

Senior+$245M raised

Summary The Senior Director of Clinical Operations oversees all aspects of clinical trial execution, including start-up, monitoring, and close-out activities for all ARTBIO programs. This key role leads the clinical oper…

Skills: Clinical Trial Execution, CRO Management, Project Management, Good Clinical Practices, ICH Guidelines

ARTBIO logo

Senior Clinical Trial Manager

ARTBIO

Cambridge, Massachusetts, United States • On-site

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Senior

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  • Full-time
  • bachelor degree, postgraduate degree
  • Posted 3d ago
  • ~40 hrs/week

Responsibilities

The Senior Clinical Trial Manager leads day-to-day clinical trial activities, managing CROs, vendors, and clinical sites to ensure deliverables are met on time and within budget. They serve as the cross-functional lead for trial execution, overseeing data integrity, regulatory compliance, and risk mitigation.

Requirements

Candidates must have a Bachelor's or Master's degree in Life Sciences or a related field with 5 to 8 years of clinical operations experience in a biotech or pharmaceutical company. Extensive experience in US clinical site management and oncology is required, along with strong knowledge of GCP, ICH, and FDA regulations.

Full 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.\nResponsibilities
  • 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.
\n

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 [email protected]. 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.

Related keywords

Clinical TrialsPhase 1Phase 2OncologySolid TumorsRadiopharmaceuticalsAlpha Radioligand TherapiesGCPICHFDACROCase Report FormsSource DocumentsSOPsICFsCRFs

About ARTBIO

LinkedInVisit site

Channeling Energy. Changing Lives.

Industry
Biotechnology Research
Company size
51-200 employees
Headquarters
Cambridge, Massachusetts
LinkedIn followers
12,850
Total funding
$245M

Cancer is relentless. So are we. 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.

Offices: Kendall Sq, c/o Alexandria LaunchLabs B200, Suite 001, Cambridge, Massachusetts 02139, US · Gaustadalléen 21, Oslo Science Park, Oslo, 0349, NO · Aeschengraben 9, Basel, BS 4051, CH · 77 New Cavendish Street, The Harley Building, London, England W1W 6XB, GB · 62 Lygon St, Suite 1, Level 3, Carlton, Victoria 3053, AU

HospitalHealth CareMedical DeviceBiotechnologyMedicalPharmaceutical
View all jobs at ARTBIO

About ARTBIO

LinkedInVisit site

Channeling Energy. Changing Lives.

Industry
Biotechnology Research
Company size
51-200 employees
Headquarters
Cambridge, Massachusetts
LinkedIn followers
12,850
Total funding
$245M

Cancer is relentless. So are we. 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.

Offices: Kendall Sq, c/o Alexandria LaunchLabs B200, Suite 001, Cambridge, Massachusetts 02139, US · Gaustadalléen 21, Oslo Science Park, Oslo, 0349, NO · Aeschengraben 9, Basel, BS 4051, CH · 77 New Cavendish Street, The Harley Building, London, England W1W 6XB, GB · 62 Lygon St, Suite 1, Level 3, Carlton, Victoria 3053, AU

HospitalHealth CareMedical DeviceBiotechnologyMedicalPharmaceutical
View all jobs at ARTBIO

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