CRA Manager

Job Description

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is accountable to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company 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 and properly manage situation of low or non-performance.
The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
 

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

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 CRAs, PLMS 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 CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
• Attend local Investigator Meetings if requested to.
• Interface with GCTO partners on clinical trial execution.
• Escalates site performance issues to CRM and 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 standard

Qualifications

Education and Minimum Requirements:

Bachelor's Degree (or higher) in relevant scientific area.

Required Experience:  

• Minimum of 5 years´ experience within Clinical Research
• Minimum of 3 years’ experience as CRA monitoring clinical trials
• Line management experience preferred or at the minimum team leader experience
• 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 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

Skills:

• High emotional intelligence
• Strong leadership skills with proven success in people management
• Excellent social and communication skills, conflict management
• Demonstrated ability to build relationships and to convey effectively with external customers (e.g. sites and investigators)
• Influencing skills

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R287602