Lab Lead
CertKOR AI
Vue.js
Study Start-Up Manager
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Montreal • 🇨🇦 Canada
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support the mapping and structuring of Central Radiopharmacies in Canada and US, including vendor qualification and contract negotiation support.
- Support the contracting of specialized vendors and provide legal coordination for technical agreements and contracts.
- Act as a regional point of contact for nuclear medicine infrastructure, including equipment, suppliers, and radiolabeling processes.
- Collaborate with local and global stakeholders to ensure the technical and operational feasibility of RLT studies.
- Identify gaps and propose solutions to enhance the country’s readiness and capacity for conducting radiopharmaceutical studies.
- Assist studies in securing RLT supplies, supporting with vendor process excellence during Study Start-Up (SSU) and throughout trial conduct.
- Partner with SSU, Clinical Operations, Legal, Quality, Procurement and Regulatory Affairs teams, without assuming direct responsibilities from these areas.
- Contribute to the development of regional playbooks, procedures and best practices for RLT studies.
- Oversight of selection, qualification, & management of Radiopharmacy (both central and site) activities.
- Oversight of management of nuclear medicine equipment related tasks (i.e. Dose Calibrator calibrations, Gamma Counter calibrations, SPECT/CT qualifications, PET/CT qualifications, procurement of equipment).
Requirements
- Bachelor’s degree in Pharmacy, Biomedicine, Biomedical Engineering, Medical Physics, or related fields.
- Solid knowledge of radiopharmacy and nuclear medicine, including cold kit radiolabeling processes and operation of equipment such as gamma cameras, PET/CT, and hot cells.
- Familiarity with local and international regulations applicable to radiopharmaceuticals and basic knowledge of compliance and quality standards relevant to clinical studies involving radioactive products.
- Experience in mapping and qualifying technical and logistical vendors for radiopharmaceutical studies.
- Understanding of importation, transportation, and storage processes for radioactive materials.
- Ability to read and interpret technical documents, including product dossiers, safety data sheets, clinical protocols, and technical contracts.
- Strong stakeholder management skills with technical profiles, including clinical engineers, medical physicists, pharmacists, and nuclear medicine specialists.
- Fluent in English and French.
Benefits
- Commitment to Diversity and Inclusion
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
radiopharmacynuclear medicinecold kit radiolabelinggamma camerasPET/CThot cellsvendor qualificationcontract negotiationtechnical agreementsclinical protocols
Soft skills
stakeholder managementcollaborationproblem solvingcommunicationorganizational skillslegal coordinationprocess excellenceoversighttechnical document interpretationproposal development
Certifications
Bachelor’s degree in PharmacyBachelor’s degree in BiomedicineBachelor’s degree in Biomedical EngineeringBachelor’s degree in Medical Physics
