Job Description
With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The a CRM could be responsible for a particular study for a country or a cluster.
Responsibilities include, but are not limited to
- Main Point of Contact (POC) for assigned protocols and link between Country Operations
and clinical trial team (CTT).
- Responsible for project management of the assigned studies
pro-actively plans, drives and tracks execution and performance of
deliverables/timelines/results to meet country commitments from feasibility and site
selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with
ICH/GCP and country regulations, policies and procedures, quality
standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training
needs to CRA-Manager and/or functional vendor and internal management as
needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance trains in the protocol other local roles, closely
collaborates with and supports CRAs as protocol expert and coordinates activities across the
different local country roles ensuring a strong collaboration (including the CTCs, CRAs and
COMs).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT
(as appropriate).
- Identifies and shares best practices.
- Responsible for collaboration with functional outsourcing vendors, investigators, other
external partners in assigned studies.
- As a customer-facing role, this position will build business relationships and represent
the company with investigators.
- Supports local and regional strategy development consistent with long‐term corporate needs
in conjunction with CRD, TA-Head and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical
Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs
to align on key issues/decisions across the trials. Consult with Human Health as needed.
Skills
- Knowledge in Project Management and/or site management.
- Strong organizational skills with demonstrated success in related role or discipline
required.
- Requires ability to make decisions independently and oversee important activities
relevant to clinical research activities according to predetermined global policies and
commitments with the support, oversight and supervision of the TA-Head or CRD
- Requires understanding of local regulatory environment.
- Scientific and clinical research knowledge is required.
- Understanding of clinical trial planning, management and metrics is essential as well
as the ability to focus on multiple deliverables and protocols simultaneously.
- Ability to function as a key link between Country Operations and Clinical Trial
Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment
and across countries, cultures and functions.
- Ability to manage processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and local language. The incumbent must be
competent and effective in written and verbal communication.
- Strategic thinking.
- Ability to work efficiently in a remote and virtual environment.
- Aptitude for building leadership skills that enable and drive alignment with the goals,
purpose and mission of the company, Global Clinical Development
(GCD) and GCTO.
- Ability to identify problems, conflicts and opportunities early, analyses and prepare
mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external
groups;settle differences with minimum disruption. Examples of common problems
include 1) low patient recruitment, 2) inadequate staff to meet business needs, 3)
performance or compliance issues, and 5) resolution of conflictive situations.
- Understand cultural diversity.
- Strong diplomatic and empathic skills to effectively build and maintain professional
relationships with investigators and other stakeholders.
Qualification & Experience
- 4+ years of experience in clinical research
- Bachelor degree in Science (or comparable)
- CRA experience preferred
Required Skills
Adaptability, Adaptability, Clinical Research, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Cultural Awareness, Diplomacy, Drug Development, ICH GCP Guidelines, Independent Thinking, Liaison Work, Medical Affairs, Patient Recruitment, Performance Plans, Problem Identification, Protocol Development, Protocol Management, Regulatory Compliance + 7 more
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
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
08/15/2026
- 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.
Requisition ID R412504
