Associate Manager, CRAM, GCTO

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 a 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:

of CRA capacity and needs, to provide efficient use of resources.

implementation across the country, to reduce variability and provide predictability.

commitments in a timely manner in coordination with the study CRM.

o Manage CRA – career development, performance reviews, etc., including

addressing low performance situations, and taking appropriate actions.

o 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:

Documentation Practices and ability to work within these guidelines

Behavioural Competency Expectations:

customers (e.g. sites and investigators)

Experience Requirements:

Required:

Educational Requirements:

Required:

Preferred:

Additional location(s) Compensation Information:

Required Skills:

Clinical Research Methods, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Employee Communications, Incident Reporting, Leadership, Patient Recruitment, People Management, Performance Monitoring, Quality Auditing, Relationship Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

02/28/2027 *A job posting is effective until 11:59:59PM on the day BEFORE  the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.