Senior Clinical Operations Manager
hace 1 mes
**About Us**
We are Merck, a leading pharmaceutical company dedicated to improving human lives through innovative medical treatments.
Salary Range:
$120,000 - $180,000 per year, depending on experience and qualifications.
Job Description:
This role is critical in ensuring strong monitoring in our clinical trials. As a key member of our team, you will be responsible for managing a team of 6-14 CRAs and ensuring excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
As a line manager, your role will be crucial in developing key talents by providing training, support, and mentoring to the CRAs, while also managing situations of low or non-performance.
You will work at the country level with other local stakeholders, such as CRM, to ensure alignment and development of the country capabilities. Your collaboration with country PLMs will ensure alignment across all monitoring functions, and you will contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
Responsibilities Include:
- Work allocation, staff development, and performance appraisal.
- Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
- Work with CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, reducing variability and providing predictability.
- Interacts with sites as needed to resolve site or CRA operational issues, meeting commitments in a timely manner in coordination with the study CRM.
- Attends local Investigator Meetings if requested.
- Interfaces with GCTO partners on clinical trial execution.
- Escalates site performance issues to CRM and Clinical Research Director CRD.
- People and Resource Management: manages CRA career development, performance reviews, etc., including addressing low performance situations and taking appropriate actions.
Experience Requirements:
- Minimum of 5 years' experience within Clinical Research.
- Minimum of 3 years' experience as CRA monitoring clinical trials.
- Line management experience preferred or at least team leader experience.
Education Requirements:
- Bachelor's degree in Science.
- Advanced degree (e.g. BA/BS or higher) with a strong emphasis in science and/or biology, preferred.
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