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Clinical Study Startup Manager Jobs in Raleigh, NC

Veranex

Senior Clinical Study Manager

Raleigh, NC · On-site

$125.60K - $179.63K/yr

The Senior Clinical Study Manager is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory ...

Kite Pharma

Sr Clinical Trials Manager

Raleigh, NC · On-site

$143.23K - $185.35K/yr

Works with management on departmental issues, providing input to clinical operations strategies and ... Ability to write study protocols, study reports, sections for investigator brochures, and ...

Allucent

Director, Clinical Pharmacology

Cary, NC · On-site +1

Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ... Candidates should never be submitted directly to our hiring managers, employees, or human resources ...

Allucent

Director, Clinical Pharmacology

Cary, NC · On-site +1

Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ... Candidates should never be submitted directly to our hiring managers, employees, or human resources ...

Allucent

Director, Clinical Pharmacology

Cary, NC · Remote

Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ... Candidates should never be submitted directly to our hiring managers, employees, or human resources ...

Allucent

Director, Clinical Pharmacology

Cary, NC · On-site +1

Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ... Candidates should never be submitted directly to our hiring managers, employees, or human resources ...

3B Staffing LLC

Clinical Scientist

Raleigh, NC

... study-specific issues, competing priorities, and clinical or scientific challenges. * Ensure effective, accurate, and timely communication of key issues and progress to the team and senior management.

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How much do clinical study startup manager jobs pay per hour?

As of May 28, 2026, the average hourly pay for clinical study startup manager in Raleigh, NC is $60.77, according to ZipRecruiter salary data. Most workers in this role earn between $49.33 and $68.46 per hour, depending on experience, location, and employer.

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

A Clinical Study Startup Manager requires expertise in clinical research processes, regulatory compliance, and project management, often supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), regulatory submission platforms, and Good Clinical Practice (GCP) certification is typically expected. Strong organizational, communication, and stakeholder management skills help facilitate collaboration and timely study initiation. These skills ensure smooth, compliant, and efficient study startup, which is critical for the overall success and timelines of clinical trials.

What are some common challenges faced by Clinical Study Startup Managers during the site activation process?

Clinical Study Startup Managers often encounter challenges such as varying regulatory requirements across regions, delays in site contract negotiations, and managing the collection of essential documents from multiple stakeholders. Coordinating with cross-functional teams—including regulatory affairs, legal, and clinical operations—requires strong project management and communication skills to keep timelines on track. Anticipating potential bottlenecks and proactively addressing site-specific concerns are critical for ensuring a smooth and timely study startup.

What does a Clinical Study Startup Manager do?

A Clinical Study Startup Manager oversees the initial phases of clinical trials, ensuring all regulatory, ethical, and site-specific requirements are met before a study begins. They coordinate activities such as site selection, contract negotiation, budget management, and regulatory submissions. Their goal is to streamline the startup process to minimize delays and ensure compliance with industry standards, facilitating a smooth transition to patient enrollment and study execution.

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

AspectClinical Study Startup ManagerClinical Research Coordinator
ResponsibilitiesOversees study initiation, site selection, regulatory submissions, and startup activitiesManages participant recruitment, data collection, and day-to-day study operations at sites
Required CredentialsBachelor's degree, clinical research experience, knowledge of regulationsBachelor's degree, clinical research experience, good clinical practice (GCP) training
Work EnvironmentCorporate or sponsor offices, clinical trial sitesClinical trial sites, hospitals, research centers

The Clinical Study Startup Manager focuses on preparing and initiating clinical trials, ensuring regulatory compliance and site readiness. In contrast, the Clinical Research Coordinator handles the daily operations at trial sites, managing participant interactions and data collection. Both roles require similar credentials and work in related environments, but their core responsibilities differ significantly.

What are the most commonly searched types of Clinical Study Startup jobs in Raleigh, NC? The most popular types of Clinical Study Startup jobs in Raleigh, NC are:
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What cities near Raleigh, NC are hiring for Clinical Study Startup Manager jobs? Cities near Raleigh, NC with the most Clinical Study Startup Manager job openings:
Clinical Study Startup Manager jobs near you
Senior Clinical Study Manager

Senior Clinical Study Manager

Veranex

Raleigh, NC • On-site

$125.60K - $179.63K/yr

Full-time

Posted 6 days ago

Job description

Veranex's mission as an Innovation CRO is to improve patient outcomes by accelerating our clients' innovations to market. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role:
The Senior Clinical Study Manager is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. This role involves collaborating with various stakeholders, including sponsors and regulatory authorities, to drive the successful completion of clinical studies. By managing the operational aspects of the trial, a Clinical Study Manager ensures that high-quality data is generated, contributing to the advancement of medical science and the development of new therapies.
What You Will Do:
Study Management
  • Lead day-to-day management of study activities and deliverables.
  • Serve as a liaison with stakeholders across all functional areas of the study.
  • Manage study budget and timelines.
  • Manage vendors, including the implementation and coordination of vendor scope of work (SOW).
  • Serve as a point of contact for issue escalation.
  • Interact directly with institutions and investigators, execute clinical research initiatives, and ensure alignment with strategic goals.

Study Start-Up, Site Management & Execution
  • Coordinate and support execution of study projects, including:
    • Site identification and initiation
    • Ethics and regulatory approvals
    • Contracting
    • Site budgeting and invoicing
    • Site staff training
    • Site initiations, routine monitoring, and close-out activities
  • Identify and establish the suitability of study investigators and sites and liaise with them to ensure compliance with all study requirements, approvals, and agreements.
  • Lead the development and implementation of key study documents, including study-specific plans, monitoring plans, study reference manuals, and source document templates.
  • Lead the execution of clinical studies, evaluation and analysis of clinical data, and preparation/review of clinical study reports.

Quality, Compliance & Oversight
  • Oversee maintenance of clinical and regulatory files, ensuring accurate and timely tracking and documentation.
  • Oversee the development of clinical reports supporting regulatory submissions.
  • Oversee monitoring of study conduct and progress, including proactive identification and resolution of issues impacting quality, timelines, budget, or compliance.
  • Identify and mitigate quality risks and/or issues associated with assigned studies and activities.
  • Ensure study conduct complies with ethical and regulatory standards, SOPs, GCP, and local regulations.

Performance Tracking & Reporting
  • Lead the collection, tracking, and reporting of key performance indicators (KPIs), including:
    • query resolution
    • safety data collection/issues
    • product/device reconciliation and shipment
    • site and patient enrollment
    • protocol deviations

Strategic & Business Support
  • Contribute to business development activities as a subject matter expert (SME).
  • Generate strategy and proposal documentation as directed.

Qualifications
Required:
  • Bachelor's degree in health sciences or related discipline
  • Minimum of 5 years of relevant experience in clinical study planning, preferably within a MedTech-oriented CRO
  • Experience maintaining documentation in compliance with FDA and ISO standards
  • Ability to independently manage multiple priorities in a fast-paced environment
  • Strong organizational, analytical, and problem-solving skills
  • Excellent written and verbal communication skill

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

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