Study Operations Manager II - Vaccines - FSP

Parexel


Date: 2 days ago
City: Remote, Remote
Contract type: Contractor
Remote
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 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 7 years of relevant operational clinical trial experience required
  • Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
  • A scientific or technical degree is preferred

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

MANAGER CLAIMS AUTO, CLAIMS: NATIONAL AUTO

Allstate Canada, Remote, Remote
1 day ago
At Allstate, great things happen when our people work together to protect families and their belongings from life’s uncertainties. And for more than 90 years our innovative drive has kept us a step ahead of our customers’ evolving needs. From advocating for seat belts, air bags and graduated driving laws, to being an industry leader in pricing sophistication, telematics, and,...

Cloud Consultant - Data & Analytics

Pythian, Remote, Remote
2 days ago
Cloud ConsultantCentral/Eastern Canada | Remote |Why you?As a Cloud Consultant you work within a team of globally dispersed cloud specialists, to design and create impactful software powering enterprise data platform solutions mainly focused on Cloud Platforms. You will produce outcomes for the real customer projects and help create software artifacts enabling automation of data platform implementations and data migrations.What will...

Technical Analyst - Completed Bachelor's or Masters Level Internship

Vosyn, Remote, Remote
3 days ago
Job Title: Technical Analyst Intern- Completed Bachelor's or Masters levelLevel: Master’s Level InternshipTeam: ProductStatus: Full-timeDuration: Equivalent to minimum 520 Hours (or 3 months minimum)Work location: Remote (with hybrid options in Toronto only)Compensation: Hourly (paid in equity compensation equivalent to CAD $32-35/hourCompany OverviewAt Vosyn, we embrace the exciting, game-changing world of Artificial Intelligence, driving innovation and pioneering impactful projects across various...