Study Start-Up Manager

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 :

Desirable Requirements : (

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. We also develop and deliver treatments through other promoted and established brands which today are helping millions of patients. Over the last three years our average annual research and development investment in Canada was over $30 million and we conduct clinical trial research in every region throughout Canada.

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.

Skills Desired

Budget Clinical Monitoring Clinical Research Clinical Study Reports Clinical Trial Management Systems Clinical Trials Collaboration Data Analysis Decision Making Skills Financial Analysis Health Sciences Lifesciences

Required Experience :

Manager

Key Skills

Restaurant Experience,Customer Service,Employee Evaluation,Management Experience,Math,Employment & Labor Law,Sanitation,Leadership Experience,P&L Management,Mentoring,Supervising Experience,Restaurant Management

Employment Type : Full-Time

Experience : years

Vacancy : 1