Engagement Manager
EVERSANA
Study Start-Up Manager – Nuclear Medicine Oversight
Novartis
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $114,100 - $211,900 per year
Job Level
Mid-LevelSenior
About the role
- Support the mapping and structuring of Central Radiopharmacies in the 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 RP (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
- BS/BA 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
- 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.
- Basic knowledge of compliance and quality standards relevant to clinical studies involving radioactive products.
- Strong stakeholder management skills with technical profiles, including clinical engineers, medical physicists, pharmacists, and nuclear medicine specialists.
Benefits
- Health, life and disability benefits
- 401(k) with company contribution and match
- Generous time off package including vacation, personal days, holidays and other leaves
- Performance-based cash incentive
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
radiopharmacynuclear medicinecold kit radiolabelinggamma camera operationPET/CT operationhot cell operationvendor qualificationcontract negotiationtechnical document interpretationcompliance standards
Soft skills
stakeholder managementcollaborationproblem-solvingcommunicationorganizational skills
Certifications
BS/BA Degree in PharmacyBS/BA Degree in BiomedicineBS/BA Degree in Biomedical EngineeringBS/BA Degree in Medical Physics
