Clinical Research Associate Manager (Remote)

Merck•Rahway, NJ

8h•$142,400 - $224,100•Remote

About The Position

The Clinical Research Associate Manager oversees a team of 6–14 Clinical Research Associates (CRAs) and ensures strong monitoring, study performance, and site performance in clinical trials. Under the oversight of the Clinical Research Director or Head of Site Management and Monitoring, the role ensures adherence to local regulations, company standard operating procedures, and ICH GCP. The manager develops CRA talent through training, support, and mentoring, and addresses low or non-performance. Working at the country level, the role partners with Clinical Research Managers and country Partner Line Managers to align monitoring functions, processes, and protocol implementation. It contributes to headquarters capacity and resource planning to support efficient allocation of staff and work. The position primarily supports Vaccine and Infectious Disease studies, with some Cardiovascular therapeutic-area work. This is a remote position with 50% travel.

Requirements

At least 5 years of experience in Clinical Research.
At least 3 years of experience monitoring clinical trials as a CRA.
Bachelor’s degree in Science.
Fluency in the local language and business proficiency in English, verbally and in writing.
Excellent working knowledge of 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.
Ability to work independently and in a team environment.
Excellent people management, time management, project management, and organizational skills.
History of strong performance.
Sound judgment and skills to make responsible decisions on behalf of the company.
High emotional intelligence.
Strong leadership skills and demonstrated success in people management.
Excellent interpersonal, communication, and conflict-management skills.
Ability to build relationships and communicate effectively with external customers, including sites and investigators.
Influencing skills.

Nice To Haves

Line-management experience; team-leader experience is acceptable at minimum.
An advanced degree with a strong emphasis in science and/or biology.
Experience or skills related to cardiovascular research, infectious disease research, or vaccine research.

Responsibilities

Allocate work, develop staff, and conduct performance appraisals.
Support departmental company initiatives and workstreams.
Contribute to capacity planning by reporting current staffing and forecasting CRA capacity and needs.
Work with CRAs, Partner Line Managers, and other functions to promote consistent processes and protocol implementation across the country.
Interact with sites as needed to resolve site or CRA operational issues in coordination with the study Clinical Research Manager.
Attend local Investigator Meetings when requested.
Interface with global clinical trial operations partners on trial execution.
Escalate site performance issues to the Head of Site Management and Monitoring.
Manage CRA career development and performance reviews, address low performance, and take appropriate action.
Support CRAs and resolve issues they escalate.
Liaise with local HR and finance functions as required.
Manage local conflicts between available resources and work needs.
Provide CRA training, support, and mentoring for continuous development.
Ensure CRA compliance with corporate policies, procedures, and quality standards.