Clinical Research Associate Manager

2 weeks ago

Toronto, Canada Merck Sharp & Dohme Full time

**Clinical Research Associate Manager**

**Based in Greater Toronto Area (GTA), Ontario**

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates and to ensure excellent study and site performance with strict adherence to local regulations, company Standard Operating Procedures and International Council for Harmonisation Good Clinical Practice.As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the Clinical Research Associates and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder e.g. Clinical Research Managers to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Mangers to ensure alignment across all monitoring functions. The person contributes to Headquarters capacity/resource planning activities to ensure efficient allocation of resources and work.

**Your key assignments as Clinical Research Associate Manager will be to**:

- Work allocation, staff development and performance appraisal.
- Provides input for capacity planning, including reporting of current manpower and forecasting of Clinical Research Associates capacity and needs, to provide efficient use of resources.
- Work with Clinical Research Associates, Partner Line Managers and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
- Interacts with sites as needed to resolve site or Clinical Research Associates operational issues to meet commitments in a timely manner in coordination with the study Clinical Research Manager.
- Attend local Investigator Meetings if requested to.
- Interface with Global Clinical Trial Operations partners on clinical trial execution.
- Escalates site performance issues to Clinical Research Manager and Clinical Research Director.

**People** **and** **Resource** **Management**:

- Manage Clinical Research Associates career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
- Help and resolve escalation of issues from Clinical Research Associates.
- Liaise with local HR and finance functions as required.
- Contribute to Headquarters capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
- Provides training, support and mentoring to the Clinical Research Associates to ensure continuous development.
- Ensures Clinical Research Associates compliance to corporate policies, procedures and quality standards
- Ability to work independently and in a team environment
- Excellent people management, time management, project management and organizational skills
- History of strong performance
- Skills and judgment required to be a good steward/decision maker for the company
- Fluent in Local Language and business proficient in English (verbal and written)
- Excellent working knowledge of all applicable International Council for Harmonisation Good Clinical Practice regulations and Good Documentation Practices and ability to work within these guidelines
- Expertise in and excellent working knowledge of core trial management systems and tools
- Strong leadership skills with proven success in people management
- Excellent interpersonal and communication skills, conflict management
- Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators
- Influencing skills

**Experience**:

- Minimum of 5 years
- with in Clinical Research
- Minimum of 3 years as Clinical Research Associate monitoring clinical trials.
- Minimum of 2 years of people management experience.
- Bachelor's degree in Science.
- Advanced degree, with a strong emphasis in science and/or biology (preferred).

**Travel**:

- Up to 50% travel

In line with our Company’s Hybrid Workplace Strategy, this position will be performed through a combination of remote work and in-person (Kirkland Head Office) based on the nature of work to be done.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Secondary** Language(s) Job Description**:
**Chef des associé(e)s, Recherche clinique**:
**Localisation: Greater Toronto Area (GTA), Ontario**:
Ce rôle sera essentiel pour faire un suivi efficace d

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