Manager, CRM, GCTO

Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Provide a key support role to TA-Head / CRD to effectively manage team, volume of clinical trials, and local/regional or global projects. The Sr. CRM may be responsible for managing a specific study for several countries within 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).

• May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.

• Responsible for project management of the assigned studies: proactively 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, company 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 across clinical trials, countries, and clusters.

• May act as a mentor.

• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.

• Country POC for programmatically outsourced trials for assigned protocols.

• As a customer-facing role, this position will build business relationships and represent the company with investigators and medical centers.

• Serves local business needs as applicable in his/her country (if delegated, can sign contracts and manage budgets).

• 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, and Global Medical Affairs to align on key issues/decisions across the trials. Consult with the commercial department as needed.

Qualifications, Skills & Experience

Skills:

• Expertise in project and site management. The position requires demonstrated success in implementing project management skills at the program and site levels.

• Strong organizational skills with demonstrated success required.

• Requires the ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.

• Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.

• Strong scientific and clinical research knowledge is required. Including extensive knowledge of the regional and/or country clinical trial landscape.

• Deep understanding of our R&D Department's organizational structure and cross-functional roles and responsibilities of its members.

• Strong understanding of clinical trial planning, management, and metrics is essential, as well as the ability to focus on multiple deliverables and execute complex protocols simultaneously.

• Experience functioning as a key link between Country Operations and Clinical Trial Teams.

• Communicates effectively and fosters a collaborative spirit in a remote/virtual environment and across countries, cultures, and functions.

• Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity, quality, and project and/or program delivery.

• Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly.

• 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.

• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

• High emotional intelligence.

• Ability to focus on multiple deliverables and protocols/projects simultaneously.

• Exercise strategic thinking and execute effectively across projects.

• Fosters understanding of cultural diversity.

• Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our R&D Department, Global Clinical Development (GCD), and Clinical Operations Team.

• Ability to identify problems, conflicts, and opportunities early and lead, analyze, and creatively 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.

4) Working with regulatory issues and the broader organization.

5) Resolution of conflictive situations.

• Educational/pedagogic, diplomatic, and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience:

Required:

• 10+ years of experience in clinical research with demonstrated success and increasing responsibilities, of which 5+ years consisted of leading projects.

• Bachelor’s Degree in Science (or comparable)

Preferred:

• CRA Experience preferred.

• Advanced degree (e.g., Master’s Degree, MD, PhD)

Required Skills:

Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Good Clinical Practice (GCP), Interpersonal Relationships, Ocular Pathology, Ophthalmology

Preferred Skills:

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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:

04/17/2026

*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.