Clinical Research Associate Manager - Neurology (Remote)
About The Position
The Clinical Research Associate Manager is responsible for managing a team of 6–14 Clinical Research Associates (CRAs) and ensuring strong monitoring, excellent study and site performance, and adherence to local regulations, company SOPs, and ICH GCP. The role operates under the oversight of the Clinical Research Director or Head of Site Management and Monitoring. As a line manager, the role develops CRA talent through training, support, and mentoring; conducts performance management; and addresses low or non-performance. At the country level, the manager works with Clinical Research Managers and Partner Line Managers to align monitoring functions and develop country capabilities. The position also contributes to headquarters capacity and resource planning to support efficient allocation of people and work. The role is remote, based in the United States, with up to 50% travel. The primary location listed is Rahway, New Jersey.
Requirements
- Bachelor’s degree in Science.
- At least 5 years of experience in Clinical Research.
- At least 3 years of experience as a CRA monitoring clinical trials.
- Fluency in the local language and business proficiency in English, both verbal and written.
- 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 decisions in the company's interests.
- 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.
- High emotional intelligence.
- Strong leadership skills and demonstrated success in people management.
- Excellent interpersonal and communication skills, including conflict management.
- Ability to build relationships and communicate effectively with external customers such as sites and investigators.
- Influencing skills.
Nice To Haves
- Line management experience; team leader experience is acceptable at minimum.
- An advanced degree, such as a BA/BS or higher, with a strong emphasis in science and/or biology.
Responsibilities
- Allocate work, develop staff, and conduct performance appraisals.
- Provide input to capacity planning, including reporting current manpower 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 clinical sites as needed to resolve site or CRA operational issues and meet commitments in coordination with the study Clinical Research Manager.
- Attend local Investigator Meetings when requested.
- Interface with Global Clinical Trial Organization partners on clinical trial execution.
- Escalate site performance issues to the Clinical Research Manager and Clinical Research Director.
- Manage CRA career development and performance reviews, address low-performance situations, and take appropriate actions.
- Support CRAs and resolve escalated issues.
- Liaise with local human resources and finance functions as required.
- Contribute to headquarters capacity and resource planning and manage local conflicts between available resources and work.
- Train, support, and mentor CRAs to foster their ongoing development.
- Ensure CRA compliance with corporate policies, procedures, and quality standards.
Benefits
- Medical insurance and healthcare benefits for employees and family.
- Dental insurance.
- Vision insurance.
- Other insurance benefits.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
