CRA Manager (CRA Line Manager)
Merck USA
Montréal, QC
Requisition ID: CLI007977

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. With a diversified portfolio of prescription medicines, vaccines and animal health products, Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Right now, we are in the process of assembling our dream team—a group of scientifically diverse individuals inspired to invent in an environment of relentless curiosity and spirited collaboration. The best of the best. Is this you?

CRA Manager (Line Manager)
Location: Montreal or Quebec city (home based position).

This role will be key to ensure business continuity in the area of monitoring in clinical research. Under the oversight of the Head of Monitoring Resources the person is responsible to manage a team of 6-12 CRAs and to ensure excellent study performance with strict adherence to local regulations, Merck SOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs.

The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

Responsibilities include, but are not limited to:
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 CRA 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 operational issues to meet commitments in a timely manner.
Attend local Investigator Meetings as necessary.
Interface with GCTO partners on clinical trial execution.
Escalates site performance issues to Clinical Research Director CRD.

People and Resource Management:
Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
Support and resolve escalation of issues from CRAs.
Liaise with local HR and finance functions as required.
Contribute to HQ 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 CRA to ensure continuous development.
Ensures CRA compliance to corporate policies, procedures and quality standards
This position is home-based

Qualifications

Minimum of 2 years´ experience with CRA people management
Minimum of 3 years´ experience as CRA monitoring clinical trials
Bachelors degree in Science or equivalent healthcare experience
Preferred: Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
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 and French (verbal and written)
Excellent working knowledge of all applicable ICH/GCP 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
High emotional intelligence
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

Travel:
Ready to travel up to 50% of working time

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. Merck is an equal opportunity employer, proudly embracing diversity in all of its manifestations.

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Job: Clinical Research Monitor

Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1

Shift (if applicable):Hazardous Materials:
Company Trade Name: Merck