Clinical Research Manager, Remote

MSD•Rahway, NJ

1d•$142,400 - $224,100•Remote

About The Position

The Clinical Research Manager (CRM) is accountable for end-to-end performance and project management of assigned clinical protocols in one country, or in some cases several countries in a cluster. The role ensures compliance with ICH Good Clinical Practice (GCP), country regulations, company policies and procedures, quality standards, and internal and external adverse-event reporting requirements. It serves as the main point of contact for assigned protocols and a link between Country Operations and the clinical trial team. The CRM plans, drives, and tracks study deliverables and timelines from feasibility and site selection through recruitment, execution, and closeout. The role leads local study teams, supports CRAs as a protocol expert, coordinates local roles, manages study risks and systems, and collaborates with investigators, vendors, external partners, and internal functions. It is a customer-facing position that builds business relationships and represents the company with investigators. The position is remote, with 25% travel and a first-shift schedule.

Requirements

At least 5 years of experience in clinical research.
Bachelor’s degree in science or comparable qualification.
Knowledge of project management and site management.
Strong organizational skills, with demonstrated success.
Ability to make independent decisions and oversee clinical research activities in accordance with global policies and commitments, with support and oversight from the TA Head or Clinical Research Director.
Strong understanding of the local regulatory environment.
Strong scientific and clinical research knowledge.
Understanding of clinical-trial planning, management, and metrics, and ability to manage multiple deliverables and protocols simultaneously.
Ability to communicate effectively and collaborate in remote/virtual settings and across countries, cultures, and functions.
Ability to manage resource allocation, processes and controls, productivity, quality, and project delivery.
Proficiency in written and spoken English and the local language, with effective written and verbal communication skills.
Strategic thinking.
Strong leadership skills to align teams with the goals and mission of Research Labs, Global Clinical Development, and Global Clinical Trial Operations.
Ability to identify problems, conflicts, and opportunities early; analyze issues, prepare mitigation plans, and drive conflict resolution.
Ability to negotiate effectively with internal and external groups and resolve differences with minimal disruption.
Educational, diplomatic, and empathetic skills to build and maintain professional relationships with investigators and other external stakeholders.

Nice To Haves

Advanced degree, such as a master’s degree, MD, or PhD.
Clinical Research Associate (CRA) experience.
At least 3 years of oncology experience.
Prior experience with lung cancer studies.
Study management experience.
Preferred skills include clinical research, process improvements, and strategic thinking.

Responsibilities

Serve as the main point of contact for assigned protocols and link Country Operations with the clinical trial team.
Manage assigned studies, proactively planning, driving, and tracking deliverables, timelines, and results from feasibility and site selection through recruitment, execution, and closeout.
Ensure assigned protocols comply with ICH/GCP, country regulations, company policies and procedures, quality standards, and adverse-event reporting requirements.
Review Monitoring Visit Reports and escalate performance issues and training needs to CRA managers, vendors, and internal management as needed.
Perform quality control visits as required.
Lead local study teams, train local roles on protocols, support CRAs as a protocol expert, and coordinate activities across local country roles.
Create and execute local risk management plans for assigned studies.
Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
Escalate challenges and issues to the TA Head, Clinical Research Director, Clinical Quality Management, or clinical trial team as appropriate.
Collaborate with functional outsourcing vendors, investigators, and other external partners.
Serve as the country point of contact for programmatically outsourced trials for assigned protocols.
Support local business needs and, if delegated, sign contracts and manage budgets.
Collaborate with headquarters and local Pharmacovigilance, Regulatory, and Global Medical Affairs functions to align on key study decisions; consult Human Health as needed.
Build business relationships with investigators and represent the company in this customer-facing role.
Share protocol-specific information and best practices across countries and clusters.