CRA Function Manager job in Chicago
|Employer:|| Merck & Co.|
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. 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. Merck Research Laboratories 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.
The CRA Manager manages the performance of a team of Oncology CRA's to support business needs.
Duties and responsibilities include, but are not limited to the following:
• 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/Merck partners on clinical trial execution.
• Escalates site performance issues to Oncology Clinical Research Director.
• People and Resource Management:
• Manage CRA - career development, performance reviews, etc. 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 is a remote/Home-based role. The CRA Manager will be located within the geographic area of responsibility where practical.
*Preferred candidate will reside within the territory.
• Required: BA/BS
• Preferred: BA/BS or higher with a strong emphasis in science and/or biology
• A minimum of 2 years CRA management experience
• A minimum of 3 years' experience as a CRA monitoring Oncology studies.
• Possess the ability to work independently and in a team environment.
• Excellent people management, time management, project management, organizational, and communication skills (written and verbal) in local language and English
• History of strong performance
• Expertise in and excellent working knowledge of core systems and tools
• Skills and judgment required to be a good steward/decision maker for the company.
• Proficient in the use of core trial management systems.
• Possess an excellent working knowledge of all applicable ICH/GCP regulations
• Close proximity to a major airport and able to travel up to 50% as needed
• Located in the Texas or Chicago area
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.
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