This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs)and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.
As Associate Director, 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. Clinical Research Managers (CRM) to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Managers (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.
This person will work primarily in Vaccine/Infectious Disease with some Cardiovascular therapeutic areas.
Responsibilities:
Work allocation, staff development and performance appraisal.
Support departmental company initiatives and workstreams.
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 Head of Site Management and Monitoring.
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 standards
Qualifications, Skills & Experience:
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)
Influencing skills
Experience Requirements:
Required:
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
Educational Requirements:
Required:
Bachelor’s degree in Science
Preferred:
Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology
#eligibleforERP
#clinicaltrialjobs
Required Skills:
Clinical Research, Clinical Research Methods, Clinical Study Management, Clinical Study Protocols, Clinical Trials Marketing, Conflict Management, Continuous Development, Data Reporting, Ethical Standards, Global Coordination, ICH GCP Guidelines, Liaison Work, Multiple Therapeutic Areas, Organizational Leadership, People Leadership, People Management, Performance Monitoring, Regulatory Compliance, Resource Allocation, Resource Deployment, Resource Planning, Site Operations, Situational Leadership, Standards Compliance, Study Monitoring
Preferred Skills:
Cardiovascular Research, Infectious Disease, Infectious Disease Research, Line Management, Task Organization, Team Organization, Time Management, Vaccine Research
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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The primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$142,400.00 - $224,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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:
50%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/23/2026A 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.
