Senior Research Operations Manager
1 day ago
We are a global Contract Research Organization (CRO) dedicated to providing high-quality clinical research services. Our team of experts is passionate about bringing new medicines to market and improving patient outcomes.
Job DescriptionWe are seeking a skilled Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI CRO Ag, you will work closely with project stakeholders to ensure the successful conduct of clinical trials in various therapeutic indications.
Your key responsibilities will include:
- Supervising study activities, timelines, milestones, and schedules on the country level.
- Conducting and reporting all types of onsite monitoring visits.
- Being involved in study set-up, including site contract and budget negotiations.
- Being responsible for site communication and management.
- Ensuring consistency of all study processes and identifying country differences.
- Overseeing maintenance of study-specific and corporate tracking systems.
- Contributing to the development and update of project planning documents, essential documents, and project instructions.
- Being a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
- Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
- Developing local language materials, including informed consents and translations.
To be successful in this role, you must possess:
- A Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience.
- Minimum 4-5 years of independent on-site monitoring experience or equivalent expertise.
- Extensive experience conducting all types of monitoring visits in Phase II and/or III clinical trials.
- Proficiency in feasibility assessment and study set-up processes is highly desirable.
- Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
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