Clinical Research Manager, Associate Director Clinical Operations
2 weeks ago
We are seeking a highly motivated and experienced individual to join our team as a Clinical Research Manager. In this role, you will be responsible for managing the end-to-end performance and project management of assigned protocols in compliance with international standards and regulations. You will serve as the main point of contact between Country Operations and the clinical trial team, ensuring effective communication and coordination. Your role will be pivotal in driving the execution and performance of deliverables, timelines, and results to meet country commitments.
Act as the main point of contact (POC) for assigned protocols and serve as a link between Country Operations and the clinical trial team.
Take charge of project management for assigned studies, including planning, execution, and close out.
Ensure compliance with international standards (ICH/GCP) and local regulations, as well as company policies and procedures.
Review Monitoring Visits Reports, identify performance issues, and escalate them to the appropriate stakeholders.
Conduct quality control visits as required.
Lead and train local study teams, collaborating closely with Clinical Research Associates (CRAs) and coordinating activities across different local country roles.
Develop and execute a local risk management plan for assigned studies.
Ensure compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and other key systems.
Escalate challenges and issues to the appropriate stakeholders, such as TA Head, Clinical Research Director (CRD), or Clinical Trial Team (CTT).
Share best practices and lessons learned across clinical trials, countries, and clusters.
Build and maintain business relationships with investigators, representing our company professionally and ethically.
Provide support for local business needs, such as contract signing and budget management, as delegated.
Contribute to the development of local and regional strategies aligned with long-term corporate goals.
Collaborate with headquarters functions, regional and local operations, and other departments to align on key issues and decisions.
Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) is required; Strong knowledge of international standards (ICH/GCP) and local regulations.
Experience in managing clinical trials in multiple countries and clusters is a plus.
In-depth understanding of project management principles and tools.
Excellent leadership and team management skills.
Results-oriented mindset with a focus on quality and performance.
Proficiency in relevant software applications and systems (e.g., Flexibility for domestic and international travel as required (approx 20%)
Please, no phone calls or emails.
Regular Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Remote Shift:
Valid Driving License:
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