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Clinical Research Study Manager Jobs (NOW HIRING)

ARTHREX

Clinical Study Manager

Naples, FL

The ideal candidate would have experience managing clinical research studies from startup through closeout, overseeing site operations, CRO activities, data collection, investigational product ...

Arthrex

Clinical Study Manager

Naples, FL · On-site

Manage clinical research studies from intake through closeout. * Monitor the management of and collection of data. * Ensures compliance with the Clinical Trial Management System (CTMS), Electronic ...

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How much do clinical research study manager jobs pay per year?

As of Jun 8, 2026, the average yearly pay for clinical research study manager in the United States is $107,336.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,000.00 and $122,500.00 per year, depending on experience, location, and employer.

What does a Clinical Research Study Manager do?

A Clinical Research Study Manager oversees the planning, execution, and completion of clinical trials to ensure they are conducted ethically and in compliance with regulatory standards. They coordinate with research teams, manage budgets and timelines, and ensure accurate data collection and reporting. Their role is crucial in ensuring that clinical studies run smoothly and produce reliable results that can be used for regulatory submissions or scientific publications.

What are the key skills and qualifications needed to thrive as a Clinical Research Study Manager, and why are they important?

To thrive as a Clinical Research Study Manager, you need expertise in clinical trial management, regulatory compliance, and protocol development, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and certifications such as GCP (Good Clinical Practice) are typically required. Strong organizational, leadership, and communication skills help manage cross-functional teams and ensure smooth study execution. These skills and qualifications are crucial for maintaining study integrity, meeting regulatory standards, and delivering successful clinical trial outcomes.

What are some common challenges faced by Clinical Research Study Managers in coordinating multi-site studies?

Clinical Research Study Managers often encounter challenges in ensuring consistent protocol adherence and data integrity across multiple study sites. Coordinating communication between site teams, managing timelines, and troubleshooting unexpected issues such as recruitment delays or regulatory hurdles are frequent tasks. Successful managers use strong organizational skills and proactive planning to mitigate these challenges, and often rely on regular meetings and digital tools to keep all stakeholders aligned. Establishing clear processes and fostering open communication are key to overcoming these complexities and ensuring study success.

What is the difference between Clinical Research Study Manager vs Clinical Research Coordinator?

AspectClinical Research Study ManagerClinical Research Coordinator
CredentialsBachelor's degree, often with experience in project managementBachelor's degree in health sciences or related field, certification optional
Work EnvironmentOversees multiple studies, manages teams, and coordinates with sponsorsHandles daily study activities, patient interactions, and data collection
Employer & IndustryPharmaceutical companies, CROs, academic institutionsHospitals, clinics, research sites
Search & Comparison IntentUnderstanding managerial roles, responsibilities, and qualificationsFocus on operational tasks and patient management

The Clinical Research Study Manager typically oversees multiple studies, manages teams, and liaises with sponsors, requiring project management skills. In contrast, the Clinical Research Coordinator handles daily study activities, patient interactions, and data collection at research sites. Both roles are essential in clinical research but differ in scope and responsibilities.

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Clinical Research Study Manager jobs near you
Clinical Research Study Manager

Clinical Research Study Manager

DM Clinical Research

Jersey City, NJ • On-site

Full-time

Posted 27 days ago

Job description

Clinical Research Study Manager
A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES amp; RESPONSIBILITIES
  • Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
  • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
  • Adherence and compliance to the assigned protocols at their respective site(s).
  • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
  • Sponsor-provided and IRB-approved Protocol Training
  • All relevant Protocol Amendments Training
  • Any study-specific Manuals Training as applicable
  • Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
  • Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
  • Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
  • Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
  • Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
  • Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
  • Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
  • Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
  • Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
  • Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
  • Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
  • Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
  • Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
  • Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
  • Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
  • Being prepared for and available at all required company meetings.
  • Submitting required administrative paperwork per company timelines.
  • Occasionally attending out-of-town Investigator Meetings.
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
  • Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
  • Facilitate effective communication between patients, healthcare providers, and research staff
  • Any other matters as assigned by management.
KNOWLEDGE amp; EXPERIENCE
Education:
  • High School Diploma or equivalent required
  • Bachelor's degree preferred
  • Foreign Medical Graduates preferred
Experience:
  • Minimum of 5 years experience in Clinical Research
  • Supervisory experience preferred
  • Wide therapeutic range of clinical trials experience preferred
  • Regulatory research experience is a plus
Credentials:
  • ACRP or equivalent certification is preferred
Knowledge and Skills:
  • Goals-driven while continuously maintaining quality.
  • Must be detailed-oriented, proactive, and able to take initiative.
  • Must have strong written and communication skills.
  • Must have excellent customer service skills.
  • Proficient communication and comprehension skills both verbal and written in the English language are required.
  • Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

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