Study Start-Up Manager

Novartis; Montreal; Hybrid; CAD 75,000 - 95,000; Full time

Job summary

A pharmaceutical company in Montreal is seeking a Study Start-Up Manager to provide operational support for Radioligand Therapy studies. Responsibilities include vendor coordination, collaboration with stakeholders, and contributing to best practices. Candidates should possess a Bachelor's degree in Pharmacy or related field, significant knowledge of radiopharmacy, and strong stakeholder management skills. Fluency in English and French is required. This is a full-time position with hybrid work options.

Qualifications

• Solid knowledge of radiopharmacy and nuclear medicine, including cold kit radiolabeling processes.
• Familiarity with local and international regulations applicable to radiopharmaceuticals.
• Ability to read and interpret technical documents related to clinical studies.

Responsibilities

• Support mapping and structuring of Central Radiopharmacies in Canada and US.
• Collaborate with stakeholders for the feasibility of RLT studies.
• Contribute to the development of regional playbooks for RLT studies.

Skills

Knowledge of radiopharmacy and nuclear medicine

Strong stakeholder management skills

Fluent in English and French

Education

Bachelor's degree in Pharmacy or related field

Tools

Gamma cameras

PET / CT

Job description

Job Description Summary

Location: Montreal / Toronto #LI-Hybrid

Study Start-Up Manager (focus on RLT)

This position is primarily designed to provide strategic and operational support for the implementation of clinical studies involving Radioligand Therapy (RLT) across Canada and US. While formally structured as an SSU Manager role it does not include regulatory or traditional study management responsibilities. The focus is to serve as a dedicated resource for the expansion and enablement of RLT studies considering the varying levels of experience and readiness across the region.

Job Description

Key responsibilities :

• 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 countrys 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)

Essential Requirements

• Bachelors 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

Desirable Requirements

• Previous experience in clinical research preferably with exposure to projects involving radiopharmaceuticals or nuclear medicine.
• Strategic mindset and ability to navigate complex and ambiguous environments.

At Novartis Canada we are determined to be a valued partner and advocate with a deep understanding of patient needs along the entire care journey from drug development to diagnosis to access and beyond. Part of the way we are doing this is by leveraging data technology and partnerships.

Research & Development: we focus on four core therapeutic areas: Cardiovascular Renal & Metabolic Immunology Neuroscience and Oncology.

Commitment to Diversity and Inclusion: Novartis is committed to building outstanding inclusive work environment and diverse teams representatives of the patients and communities we serve.

Employment Type: Full-Time

Experience: years

Vacancy: 1