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Merck Clinical Operations Manager Jobs in Washington

MedVanta

Clinical Manager

Falls Church, VA · On-site

Clinical Operations Management * Oversee day-to-day clinic operations, including patient flow, provider support, and clinical scheduling. * Supervise clinical support staff (MAs, ATCs, rehab aides ...

PharmaOut

Clinical Project Manager

Gaithersburg, MD

This role will be key in developing internal Clinical Operations systems and procedures to improve ... Manage day to day activities of all aspects of clinical studies including study plans, timelines ...

PDS Health

Operations Manager

Fairfax, VA · On-site

Overview The role of the Operations Manager is to achieve or exceed the budgeted financial ... Supports clinical diagnosis and referrals focusing on comprehensive patient care through education ...

PDS Health

Operations Manager

Fairfax, VA · On-site

$63K/yr

The role of the Operations Manager is to achieve or exceed the budgeted financial performance in ... Supports clinical diagnosis and referrals focusing on comprehensive patient care through education ...

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Merck Clinical Operations Manager information

What does a Merck clinical operations manager do?

A Merck Clinical Operations Manager oversees the planning, execution, and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory requirements. They coordinate cross-functional teams, manage budgets and timelines, and serve as a key liaison between internal stakeholders and external partners. Their role is critical in ensuring that clinical studies generate reliable data to support the development and approval of new medicines.

How does a Merck clinical operations manager typically collaborate with cross-functional teams during a clinical trial?

As a Clinical Operations Manager at Merck, you will regularly collaborate with cross-functional teams such as clinical research associates, data management, regulatory affairs, medical writing, and biostatistics. Your role involves facilitating clear communication to ensure trial milestones are met, addressing operational challenges, and aligning on project goals. You will often lead meetings, coordinate with internal and external stakeholders, and ensure that all teams are updated on timelines, compliance, and protocol changes. This collaborative environment is essential for delivering high-quality clinical studies efficiently and in accordance with regulatory standards.

What are the key skills and qualifications needed to thrive as a Merck clinical operations manager, and why are they important?

To thrive as a Merck Clinical Operations Manager, you need a strong background in clinical research, project management, and a relevant degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), regulatory compliance, and certifications like PMP or GCP are commonly required. Exceptional leadership, problem-solving, and communication skills distinguish top performers in this role. These skills ensure the effective execution of clinical trials, regulatory adherence, and successful cross-functional team collaboration.

What is the difference between Merck Clinical Operations Manager vs Merck Clinical Research Associate?

AspectMerck Clinical Operations ManagerMerck Clinical Research Associate
ResponsibilitiesOversees clinical trial operations, manages teams, ensures compliance, and coordinates with stakeholders.Supports site activities, monitors trial progress, and ensures data accuracy at clinical sites.
Required CredentialsBachelor's degree in life sciences, project management experience, knowledge of GCP guidelines.Bachelor's degree in health sciences or related field, clinical trial monitoring experience.
Work EnvironmentOffice-based with site visits, team management, strategic planning.Primarily site visits, monitoring activities, and data collection.

The Merck Clinical Operations Manager focuses on overseeing entire clinical trial processes and managing teams, while the Merck Clinical Research Associate primarily supports site-level activities and monitors trial progress. Both roles require relevant clinical experience and knowledge of GCP guidelines, but differ in scope and responsibilities.

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For Merck Clinical Operations Manager jobs in Washington, the most frequently searched job titles are:

What job categories do people searching Merck Clinical Operations Manager jobs in Washington look for?

The top searched job categories for Merck Clinical Operations Manager jobs in Washington are:

What cities in Washington are hiring for Merck Clinical Operations Manager jobs?

Cities in Washington with the most Merck Clinical Operations Manager job openings:

Merck Clinical Operations Manager jobs near you

Sr. Clinical Operations Lead (Clinical Trial Manager)

Alimentiv

Washington, DC • Remote

$86K - $143K/yr

Full-time

Re-posted 2 days ago

Job description

Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.
Project Oversight
  • Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.
  • Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
  • May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
  • Oversee regional startup and feasibility activities.
  • Assist in vendor management activities as required per project.
  • Perform review of visit reports for quality, compliance and appropriate site management.
  • Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
  • Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.
  • Contribute to financial project management processes as applicable.  May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
  • May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.         
Project Liaison
  • Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls 
  • Attend meetings with Study Sponsor to provide status updates on country and site progress
  • Provide operational support and guidance to the monitoring team throughout project.
  • Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.
  • First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
  • Support line managers by providing status updates on utilization and performance of CRAs. 
  • Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project. 
  • Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.
Study Documents and Plans
  • Develop training materials and study tools for sites and CRAs, including monitoring plans.
  • Develop and implement enrolment and recruitment strategies together with clinical project team.
  • Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.
 
Qualifications
  • College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
OR
  • Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
Other
  • Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
  • Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
  • Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
  • Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
  • Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment. 
 
Working Conditions
  • Home-based
+ Bonus
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com
 
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.
 

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