Job Description

Brief Description of Position

With the 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, company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

The aCRM could be responsible for a particular study for a country or a cluster.
Responsibilities include, but are not limited to:

• The Main Point of Contact (POC) for assigned protocols and the link between Country Operations and the 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 closeout.
• Accountable for the performance of 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.
Review monitoring visit reports and escalate performance issues and training needs to the CRA Manager and/or functional vendor and internal management as needed.
o Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol of other local roles, closely collaborates with and supports CRAs as protocol experts, 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 different challenges and issues to TA-Head/CRD/CCQM and/or CTT (as appropriate) as needed.
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, and 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.

Qualifications, Skills & Experience

Skills:
• Knowledge of Project Management and/or site management.
• Strong organizational skills with demonstrated success in related roles or disciplines 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 the local regulatory environment.
• Scientific and clinical research knowledge is required.
• Understanding clinical trial planning, management, and metrics is essential, as is 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 our R&D department, Global Clinical Development (GCD), and GCTO.
• It is critical to be able to identify problems, conflicts, and opportunities early, analyze and prepare mitigation plans, and drive conflict resolution.
• 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's degree in Science (or comparable)
• CRA experience preferred

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:

04/30/2025

*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.