Clinical Trial Operations Manager
Parexel
Behavioral Health Market Context
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Job Description
on and communication.
• Provide backup support and assume responsibilities as needed for the Global Study Manager (GSM).
• Oversee the selected Contract Research Organization (CRO) and/or Country Trial Manager, ensuring adherence to project plans and maintaining accurate country-level timelines, budgets, and quality metrics.
• Manage or supervise the study start-up process within assigned countries, coordinating with CROs as needed.
• Work closely with Site Care Partners, regulatory teams, and other stakeholders to establish submission strategies to Health Authorities (HAs) and Ethics Committees (ECs).
• Provide country-specific insights regarding startup and recruitment milestones during the planning phase.
• Collaborate with team roles to identify and address any deviations and risks during study execution, applying effective mitigation strategies.
• Ensure the resolution of site activation escalations, offering options for mitigation to study teams.
• Take full accountability for the implementation of startup and site activation strategies, as defined by the GSM, including recruitment strategies and development of study-specific plans.
• Communicate effectively with local teams and internal stakeholders, ensuring timely and efficient study delivery.
• Oversee vendor management and ensure timely coordination of deliverables according to study plans.
• Ensure thorough follow-up on regional and site quality events, protocol deviations, data issues, and other necessary metrics for continuous improvement.
Requirements:
• Bachelor's degree in Science or Arts with at least 5 years of relevant clinical trial experience.
• Master's degree in Science or Business Administration with a minimum of 3 years of relevant experience is also acceptable.
• A technical or scientific background is preferred.
#LI-REMOTE
EEO Disclaimer: Parexel is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
• Provide backup support and assume responsibilities as needed for the Global Study Manager (GSM).
• Oversee the selected Contract Research Organization (CRO) and/or Country Trial Manager, ensuring adherence to project plans and maintaining accurate country-level timelines, budgets, and quality metrics.
• Manage or supervise the study start-up process within assigned countries, coordinating with CROs as needed.
• Work closely with Site Care Partners, regulatory teams, and other stakeholders to establish submission strategies to Health Authorities (HAs) and Ethics Committees (ECs).
• Provide country-specific insights regarding startup and recruitment milestones during the planning phase.
• Collaborate with team roles to identify and address any deviations and risks during study execution, applying effective mitigation strategies.
• Ensure the resolution of site activation escalations, offering options for mitigation to study teams.
• Take full accountability for the implementation of startup and site activation strategies, as defined by the GSM, including recruitment strategies and development of study-specific plans.
• Communicate effectively with local teams and internal stakeholders, ensuring timely and efficient study delivery.
• Oversee vendor management and ensure timely coordination of deliverables according to study plans.
• Ensure thorough follow-up on regional and site quality events, protocol deviations, data issues, and other necessary metrics for continuous improvement.
Requirements:
• Bachelor's degree in Science or Arts with at least 5 years of relevant clinical trial experience.
• Master's degree in Science or Business Administration with a minimum of 3 years of relevant experience is also acceptable.
• A technical or scientific background is preferred.
#LI-REMOTE
EEO Disclaimer: Parexel is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Qualifications
- •Bachelor's degree in Science or Arts with at least 5 years of relevant clinical trial experience
- •Master's degree in Science or Business Administration with a minimum of 3 years of relevant experience is also acceptable
Benefits
Responsibilities
- •The Clinical Trial Operations Manager plays a crucial role in leading and managing the operational aspects of one or more clinical studies from initiation through completion
- •This role demands strong leadership, strategic planning, and organizational skills to ensure effective delivery of study tasks and objectives
- •Lead the local study team for one or more clinical trials, fostering collaboration and communication
- •Provide backup support and assume responsibilities as needed for the Global Study Manager (GSM)
- •Oversee the selected Contract Research Organization (CRO) and/or Country Trial Manager, ensuring adherence to project plans and maintaining accurate country-level timelines, budgets, and quality metrics
- •Manage or supervise the study start-up process within assigned countries, coordinating with CROs as needed
- •Work closely with Site Care Partners, regulatory teams, and other stakeholders to establish submission strategies to Health Authorities (HAs) and Ethics Committees (ECs)
- •Provide country-specific insights regarding startup and recruitment milestones during the planning phase
- •Collaborate with team roles to identify and address any deviations and risks during study execution, applying effective mitigation strategies
- •Ensure the resolution of site activation escalations, offering options for mitigation to study teams
- •Take full accountability for the implementation of startup and site activation strategies, as defined by the GSM, including recruitment strategies and development of study-specific plans
- •Communicate effectively with local teams and internal stakeholders, ensuring timely and efficient study delivery
- •Oversee vendor management and ensure timely coordination of deliverables according to study plans
- •Ensure thorough follow-up on regional and site quality events, protocol deviations, data issues, and other necessary metrics for continuous improvement
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