Study Operations Manager – Clinical Trial Manager
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Job Description
Study Operations Manager overseeing operational delivery of clinical trials. Managing study activities, ensuring compliance with regulations, and coordinating with stakeholders in various regions and countries.
Responsibilities:
- Responsible for study and regional or specific country level activities from study startup through conduct and study close on one or more studies
- Serves as leader of the local study team on one or more studies
- 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
- 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
- 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
- Fully responsible and accountable for regional, country, and study level implementation of startup and site activation 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
Benefits:
- Health insurance
- Professional development
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