Country Study Operations Manager

6 days ago

Ottawa, Canada Parexel Full time

The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.
- Serves as leader of the local study team on one or more studies
- Provides back up to or assumes the responsibilities of the GSM as needed
- Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
- May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
- Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
- Provides country level input on startup and recruitment milestones during planning
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
- Accountable for resolution of site activation escalations to study teams including offering options for mitigation
- Fully responsible and accountable for, as designated by the GSM:

- Regional, country, and study level implementation of startup and site activation plans
- Regional, country and study level recruitment strategy
- Development of study level plans
- Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans
- Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
- Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.

**Requirements**:

- Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
- A scientific or technical degree is preferred

LI-LO1

LI-REMOTE

  • Study Operations Manager Ii

    6 days ago

    Ottawa, Canada Parexel Full time

    The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. - Serves as leader of the local study team on one or...

  • Study Operations Manager Ii

    2 weeks ago

    Ottawa, Canada Parexel Full time

    The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. **Study Management Oversight** - Serves as leader...

  • Study Operations Manager

    2 days ago

    Ottawa, Canada Parexel Full time

    **Job Summary**: The Study Operations Manager (SOM) has responsibilities for study and regional or specific country level activities in Canada from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention). **Key...

  • Study Start Up Project Manager

    7 days ago

    Ottawa, Canada Parexel Full time

    The Start Up Project Manager is responsible for defining, developing and delivering the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine,...

  • Country Manager

    2 weeks ago

    Ottawa, Ontario, Canada INVEST OTTAWA Full time

    Ottawa's tech sector is growing, and so are the opportunities If you're exploring your next role in tech, Work in Ottawa can help you learn about leading employers and exciting careers in Canada's capital.Led by Invest Ottawa, the city's lead economic development agency, this initiative works alongside tech companies, recruiters and search firms, and...

  • Country Manager

    2 weeks ago

    Ottawa, Ontario, Canada Work in Ottawa Full time

    Ottawa's tech sector is growing, and so are the opportunities If you're exploring your next role in tech,Work in Ottawacan help you learn about leading employers and exciting careers in Canada's capital.Led by Invest Ottawa, the city's lead economic development agency, this initiative works alongside tech companies, recruiters and search firms, and community...

  • Country Manager

    2 weeks ago

    Ottawa, Canada Work in Ottawa Full time

    Base pay range CA$260,000.00/yr - CA$300,000.00/yr Country Manager – Canada We are excited to partner with ITHQ to attract top talent for their new Country Manager – Canada. Introduction ITHQ’s expansion into Canada represents a significant strategic milestone for the business. This move is driven by three core objectives: Market Diversification and...

  • Country Manager

    2 weeks ago

    Ottawa, Canada Work in Ottawa Full time

    Ottawa’s tech sector is growing, and so are the opportunities! If you’re exploring your next role in tech, Work in Ottawa can help you learn about leading employers and exciting careers in Canada’s capital. Led by Invest Ottawa, the city’s lead economic development agency, this initiative works alongside tech companies, recruiters and search firms,...

  • Country Manager

    2 weeks ago

    Ottawa, Canada Work in Ottawa Full time

    Ottawa’s tech sector is growing, and so are the opportunities! If you’re exploring your next role in tech, Work in Ottawa can help you learn about leading employers and exciting careers in Canada’s capital. Led by Invest Ottawa, the city’s lead economic development agency, this initiative works alongside tech companies, recruiters and search firms,...

  • Country Manager

    2 weeks ago

    Ottawa, Canada Work in Ottawa Full time

    Work in Ottawa is an initiative of Invest Ottawa, the economic development agency with a mandate of facilitating economic growth and job creation for the city of Ottawa. As a hub for innovation and growth, Ottawa is home to a vibrant tech job market that beckons top talent from around the globeOttawa’s leading employers are on the lookout for professionals...