Driving global trials to success through strategic oversight, seamless operations, and patient鈥慺ocused execution.
探花合集 is seeking a Manager, Clinical Operations to oversee and execute study-level activities for clinical trials. This role involves managing trial-specific documentation, vendor oversight, and ensuring smooth operational delivery across countries and regions. You will play a key role in aligning feasibility strategies, addressing challenges, and driving successful study outcomes.
Responsibilities:
- Coordinate project team activities by leveraging internal and external resources and optimizing CRO expertise.
- Contribute to trial-level operational strategies from protocol design to final clinical study reports.
- Develop and maintain global subject-patient recruitment plans.
- Build and sustain relationships with study sites and vendors.
- Oversee CRO and vendor management, including setup, budget oversight, and operational activities.
- Manage strategic study operations such as regulatory submissions, drug supply, enrollment tracking, and performance metrics.
- Create and update critical trial-specific documents, including country-specific ICFs and operational plans.
- Support the development of training materials at the compound and protocol levels.
- Review and provide input on budgets, timelines, and forecasts for clinical studies.
- Collaborate with internal stakeholders across various departments to ensure seamless trial execution.
- Support inspection readiness activities and develop risk mitigation plans.
- Participate in process improvement initiatives at both trial and departmental levels.
- Assist in onboarding new team members and provide mentorship.
- Attend and contribute to CTWG meetings, providing updates on operational progress.
- Travel as required, approximately 10%, with flexibility based on business needs.
Key Skills and Requirements:
- Degree in a relevant field (BS/BA).
- Experience in clinical research, particularly in Phase I trials, with a CRO, biotech, or pharmaceutical company.
- Familiarity with global clinical trial operations and working with CROs.
- Strong knowledge of Good Clinical Practices (GCPs) and regulatory requirements.
- Proficiency in decision-making, analytical thinking, and financial management.
- Ability to lead and foster team productivity in a matrixed, global environment.
- Experience mentoring and coaching team members.
- Exceptional organizational, problem-solving, and project management skills.
- Strong communication, presentation, and writing abilities.
- Proficiency in MS Office Suite, including Excel, Word, and PowerPoint.
If you are having difficulty in applying or if you have any questions, please contact Elis Jones at e.jones@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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