Investigational Medicinal Product Manager

1 month ago

Kingston, Canada Queen's University Full time

About Queen's University

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.
Come work with us
Job Summary
The Investigational Medicinal Product Lead is responsible for leadership of CCTG operations related to investigational medicinal product (IMP) policies and processes, procurement, distribution, and oversight essential to the conduct of national and international multi-centre clinical trials of cancer therapy in compliance with applicable guidelines, regulations, and standards.

Reporting to the Manager Office of Clinical Trial Management (Phase III/Late Phase) and working in collaboration with the Manager Early Drug Development Program (IND), the incumbent is responsible for ensuring IMP plans established are compliant and meet the needs of the study protocol and regulatory requirements. Further, the incumbent will partner with trial teams, information technology teams, as well as the Quality and Innovation leads, to ensure IMP is managed in an efficient and effective manner. This includes establishing partnerships and relationships with IMP vendors nationally and internationally and managing complex product requirements and supply challenges. The IMP Lead is accountable for overall leadership and execution of drug supply operations, ensuring the CCTG is current with applicable regulations and guidelines and best practices, collaboration with vendors and stakeholders.
**Job Description**:
**KEY RESPONSIBILITIES**:

- Manage the development of IMP supply plans and processes including development of the plan, partnership with vendors, and oversight activities (quality assurance/quality control) to ensure plans in place adhere to Good Manufacturing Practices (GMP).
- Manage drug supply operations for the CCTG, serving as liaison and resource for the OSC team, the Pharmacist Network Steering Committee, and network stakeholders. Strategically monitors drug supply and supply chain concerns to ensure the needs of CCTG clinical trials are addressed. Escalates issues and identifies solutions to concerns identified to relevant portfolio Manager (Phase III / IND), Senior Investigator/Faculty, and Senior Leadership as required. Responsible for identifying solutions to IMP scenarios such as shortages.
- Responsible for all IMP Standard Operating Procedures, Work Instructions, and generic Trial documentation for the CCTG. This includes development, review, and maintenance of this material and accountability for ensuring that CCTG remains in compliance with all applicable regulations and guidelines. Responsible for ensuring CCTG is update to date/current with the regulations, guidelines, and practices related to IMP. Initiates continuous evaluation of group IMP processes and responsible for driving process change through consultation with relevant stakeholders.
- Serves as the primary point of contact for CCTG with vendors involved in the drug supply process (e.g. Bay Area Research Logistics (BARL). Establishes and manages oversight framework for vendors involved in CCTG drug supply and ensures appropriate accountability of concerns and identifies potential solutions for CCTG consideration. Develops vendor Request For Services Plans for IMP services in partnership with the Manager Finance.
- Provide direction and compliant/effective solutions for trial teams during study start up (contract and protocol development) and well as throughout the life of a clinical trial as IMP practices change during the course of a study. Guidance and support includes, but is not limited to, procurement of investigational agent and blinded drug supply, packaging, labeling and re-labeling, frequency of supply, expiry date issues, recall, retention of samples, destruction of supplies as well as other drug accountability requirements.
- Leads and creates drug forecasting strategy for the clinical trial.
- Oversees IMP supply at centres and vendors to ensure effective expiry date is in place and to ensure drug is review, quality assurance steps are completed, and drug is destroyed in a timely manner due to financial implications.
- Responsible for management of blinded trial drug requirements in partnership with information technology and compliance teams. This individual operating outside of the trial team would have an unblinded project management role to support supply and warehouse management.
- Develop educational materials and conduct training on aspects of IMP relevant to CTG activities. Develop generic documentation such as generic pharmacy manuals that can be adopted for study-specific use.
- Establish and execute a quality assurance/quality control framework for IMP processes at CCTG.
- Key li

  • Investigational Medicinal Product Manager

    1 month ago

    Kingston, Canada Queen's University Full time

    Investigational Medicinal Product Manager About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration,...

  • Nuclear Medicine Tech

    2 months ago

    Kingston, Canada Kingston Health Sciences Centre Full time

    **Company**: Kingston Health Sciences Centre Under the direction of the Manger, Imaging Services, the Nuclear Medicine Technologist performs a variety of technical procedures that require independent judgment. Assumes responsibility for teaching new technical staff all procedures pertaining to the Division of Nuclear Medicine.Within this role the employee...

  • Divisional Assistant, Geriatric Medicine

    1 month ago

    Kingston, Canada Queen's University Full time

    Divisional Assistant, Geriatric Medicine About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration,...

  • Divisional Assistant, Geriatric Medicine

    1 month ago

    Kingston, Canada Queen's University Full time

    About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation,...

  • Sr. Product Development Engineer

    3 weeks ago

    Kingston, Canada Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Sr. Product Development Engineer

    3 weeks ago

    Kingston, Canada Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Sr. Product Development Engineer

    2 weeks ago

    Kingston, Canada Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Production Manager

    2 months ago

    Kingston, Canada Cancoil Thermal Corporation Full time

    **PURPOSE AND SCOPE** The Production Manager is responsible for both the day to day production operations within all production departments, as well as weekly & monthly area performance including output, labour productivity and quality. **ORGANIZATIONAL RELATIONSHIP** Production Manager reports directly to Chief Operating Officer. **JOB DUTIES** **a)...

  • Production Manager

    2 weeks ago

    Kingston, Canada Cancoil Thermal Corporation Full time

    **PURPOSE AND SCOPE** The Production Manager is responsible for both the day to day production operations within all production departments, as well as weekly & monthly area performance including output, labour productivity and quality. **ORGANIZATIONAL RELATIONSHIP** Production Manager reports directly to Chief Operating Officer. **JOB DUTIES** **a)...

  • Production Manager

    2 months ago

    Kingston, Canada Cancoil Thermal Corporation Full time

    **PURPOSE AND SCOPE** The Production Manager is responsible for both the day to day production operations within all production departments, as well as weekly & monthly area performance including output, labour productivity and quality. **ORGANIZATIONAL RELATIONSHIP** Production Manager reports directly to Chief Operating Officer. **JOB DUTIES** **a)...

  • Production Manager

    1 month ago

    Kingston, Canada Cancoil Thermal Corporation Full time

    **PURPOSE AND SCOPE** The Production Manager is responsible for both the day to day production operations within all production departments, as well as weekly & monthly area performance including output, labour productivity and quality. **ORGANIZATIONAL RELATIONSHIP** Production Manager reports directly to Chief Operating Officer. **JOB DUTIES** **a)...

  • Production Manager

    1 week ago

    Kingston, Canada Cancoil Thermal Corporation Full time

    **PURPOSE AND SCOPE** The Production Manager is responsible for both the day to day production operations within all production departments, as well as weekly & monthly area performance including output, labour productivity and quality. **ORGANIZATIONAL RELATIONSHIP** Production Manager reports directly to Chief Operating Officer. **JOB DUTIES** **a)...

  • Nuc. Med.tech.

    2 months ago

    Kingston, Canada Kingston Health Sciences Centre Full time

    Under the direction of the Manger, Imaging Services, the Nuclear Medicine Technologist performs a variety of technical procedures that require independent judgment. Assumes responsibility for teaching new technical staff all procedures pertaining to the Division of Nuclear Medicine. Within this role the employee is accountable for contributing to the...

  • Nuc. Med. Tech Pt

    3 weeks ago

    Kingston, Canada Kingston Health Sciences Centre Full time

    Under the direction of the Manger, Imaging Services and supervision of the Senior Nuclear Medicine Technologist, the Nuclear Medicine Technologist performs all aspects of a variety of technical procedures that require independent judgment. Participates in teaching new technical staff all procedures pertaining to the Division of Nuclear Medicine. Participates...

  • Physician Assistant

    5 days ago

    Kingston, Canada Kingston Health Sciences Centre Full time

    **Title**:Physician Assistant **Department**:Emergency Medicine **Hours of Work**:Full-Time Position; rotating (8-hour shifts) **Salary**:$40.64-$48.77 per hour **Union**:OPAA (Ontario Physician Assistant Association) **Location**: Kingston General Hospital site ***: The Hospital will ensure that the Physician Assistant (PA) participates in patient...

  • Intake Assessor for Sports Medicine/ Concussion

    2 months ago

    Kingston, Canada KOPI - Kingston Orthopaedic Pain Institute Full time

    **Intake Assessor for Sports Medicine/Concussion Physicians and Watkins Metabolic Clinic** **Full Time Career Opportunity** **Monday - Friday, Day Shifts** **$19-$23hr biased on experience** **_Kingston Orthopaedic Pain Institute (KOPI)_**was founded in 2008, offering a patient-centric multidisciplinary approach intended to improve the quality of life...

  • Research Manager

    2 months ago

    Kingston, Canada Queen's University Full time

    Research Manager About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction,...

  • Research Manager

    2 months ago

    Kingston, Canada Queen's University Full time

    About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation,...

  • Program Assistant

    3 weeks ago

    Kingston, Canada Queen's University Full time

    Program Assistant - General Internal Medicine Training Program About Queen's University Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty...

  • Project Manager, Design

    1 week ago

    Kingston, Canada Lonza Full time

    Canada, KingstonToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...