Associate Clinical Research Manager (aCRM) - Infectious Disease (REMOTE)

$111,400 - $175,300/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

In this role, you will be accountable for the end-to-end performance and project management for assigned clinical trial protocols within a specific country. This includes ensuring compliance with ICH/GCP guidelines, country regulations, and our company's policies and procedures. You will serve as the main point of contact for assigned protocols, acting as a vital link between Country Operations and the Clinical Trial Team (CTT). Your responsibilities will encompass proactive planning, driving, and tracking the execution and performance of deliverables, timelines, and results to meet country commitments from feasibility and site selection through to recruitment, execution, and closeout of studies. You will be responsible for reviewing Monitoring Visit Reports, escalating performance issues, and identifying training needs to the CRA-Manager and/or functional vendors. Additionally, you will perform quality control visits as required and lead local study teams to achieve high performance. This includes training local roles in the protocol, collaborating closely with Clinical Research Associates (CRAs), and coordinating activities across various local country roles to ensure strong collaboration. Your role will also involve creating and executing a local risk management plan for assigned studies, ensuring compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other key systems. You will escalate challenges and issues to the TA-Head, CRD, CCQM, or CTT as appropriate, and share best practices within the team. As a customer-facing role, you will build business relationships and represent our company with investigators, supporting local and regional strategy development in alignment with long-term corporate needs. Collaboration with internal functions such as EU Clinical Development, Pharmacovigilance, Regulatory Affairs, and Global Medical and Scientific Affairs will be essential to align on key issues and decisions across trials. You will also be expected to consult with Human Health as needed. This position requires travel of up to 30% of your working time, and you will need to demonstrate strong project management skills, organizational abilities, and a deep understanding of the local regulatory environment.

Responsibilities

• Act as the main point of contact for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Manage project execution for assigned studies, including planning, driving, and tracking deliverables and timelines.
• Ensure compliance with ICH/GCP, country regulations, and company policies for assigned protocols.
• Review Monitoring Visit Reports and escalate performance issues to CRA-Manager and/or functional vendors.
• Perform quality control visits as required and lead local study teams to high performance.
• Train local roles in the protocol and support CRAs as a protocol expert.
• Create and execute a local risk management plan for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
• Identify and share best practices within the team.
• Build business relationships and represent the company with investigators.
• Support local and regional strategy development in conjunction with CRD, TA-Head, and Regional Operations.
• Collaborate with internal functions to align on key issues and decisions across trials.

Requirements

• Minimum 4 years of experience in clinical research.
• Bachelor's degree in Science or a comparable field.
• Knowledge in project management and/or site management.
• Strong organizational skills with demonstrated success in related roles.
• Ability to make independent decisions and oversee clinical research activities.
• Understanding of the local regulatory environment.
• Scientific and clinical research knowledge is required.
• Understanding of clinical trial planning, management, and metrics.
• Ability to communicate effectively and build collaboration in a remote/virtual environment.
• Proficiency in written and spoken English and local language.

Nice-to-haves

• CRA experience preferred.
• Aptitude for building leadership skills that align with company goals.
• Experience in negotiating skillfully in tough situations.

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days