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 responsible 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.

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 \xe2\x80\x93 career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

Support and resolve escalation of issues from CRAs. o Liaise with local HR and finance functions as required. o Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

Manage local conflicts between resource and work. o Provides training, support and mentoring to the CRA to ensure continuous development. o Ensures CRA compliance to corporate policies, procedures and quality standards

CORE Competency Expectations:

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 Behavioral Competency Expectations:

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)

Manages a team of 6-14 employees (direct reports)

Influencing skills

Experience Requirements:

Required:

Minimum of 5 years\xc2\xb4 experience with in Clinical Research

Minimum of 3 years\xe2\x80\x99 experience as CRA monitoring clinical trials

Line management experience preferred or at the minimum team leader experience.

Educational Requirements:

Required:

Bachelor\xe2\x80\x99s degree in science

Preferred:

Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
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: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Merck Sharp & Dohme