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Clinical Study Startup Manager Jobs in Park Ridge, IL

Clinical Study Specialist I Are you a clinical operations professional who thrives on precision ... Site Startup & Activation ("Green Light"): Manage the collection, quality control, and filing of ...

Clinical Study Specialist I Are you a clinical operations professional who thrives on precision ... Site Startup & Activation ("Green Light"): Manage the collection, quality control, and filing of ...

Required Experience * 2+ years of global study management experience * Experience across multiple countries/regions * Phase I-III clinical trials experience (Phase III required) * Oncology experience ...

Required Experience * 2+ years of global study management experience * Experience across multiple countries/regions * Phase I-III clinical trials experience (Phase III required) * Oncology experience ...

The Study Project Manager I is responsible for and ensures clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project ...

Coordinate and manage clinical trials from study startup through closeout * Independently manage 3 to 4 active studies simultaneously * Recruit, screen, consent, and schedule study participants

S. clinical sites for intravenous line fluid management system clinical studies. Conduct product in-service and training for physician clinical investigators and nursing staff. Oversee clinical study ...

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Clinical Study Startup Manager information

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

As of Sep 6, 2026, the average hourly pay for clinical study startup manager in Park Ridge, IL is $61.52, according to ZipRecruiter salary data. Most workers in this role earn between $49.90 and $69.33 per hour, depending on experience, location, and employer.

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 are the key skills and qualifications needed to thrive as a clinical study startup manager?

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 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 Park Ridge, IL?

The most popular types of Clinical Study Startup jobs in Park Ridge, IL are:

What job categories do people searching Clinical Study Startup Manager jobs in Park Ridge, IL look for?

The top searched job categories for Clinical Study Startup Manager jobs in Park Ridge, IL are:

What cities near Park Ridge, IL are hiring for Clinical Study Startup Manager jobs?

Cities near Park Ridge, IL with the most Clinical Study Startup Manager job openings:

Infographic showing various Clinical Study Startup Manager job openings in Park Ridge, IL as of August 2026, with employment types broken down into 82% Full Time, 16% Part Time, 1% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $127,954 per year, or $61.5 per hour.

Clinical Study Specialist I

CellCarta

Naperville, IL • On-site

$55K - $73K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 18 days ago


Job description

Clinical Study Specialist I
Are you a clinical operations professional who thrives on precision, compliance, and process efficiency? We are looking for an energetic Clinical Study Specialist I to join our growing Clinical Operations team and support the successful execution of innovative oncology clinical trials.
Summary
In this role, you will be responsible for the operational success and integrity of site-level regulatory documentation, clinical monitoring visits, site initiation visits, close-out visits, and related action item follow-up. Acting as a central liaison between Project Management, Regulatory Affairs (RA), and Quality Assurance (QA), you will ensure that all site initiation activities (SIVs), monitoring preparation, conduct, and follow-up activities, as well as essential document collection (FDFs, CVs, and MLs), are executed with precision. You will own the action item lifecycle, driving compliance and monitoring readiness across a diverse portfolio of complex oncology trials.
Responsibilities
  • Monitoring Oversight & Action Item Management: Review third-party monitoring visit reports, log Action Items (AIs), and actively drive them to resolution by following up directly with monitors and site staff
  • Site Startup & Activation ("Green Light"): Manage the collection, quality control, and filing of site-level essential documents (Financial Disclosure Forms, updated CVs, medical licenses, and laboratory certifications) required for Site Initiation Visits (SIVs) and site activation
  • Close-Out Visit & Study Deactivation: Oversee close-out logistics and documentation, ensuring complete reconciliation of all documents and resolution of all outstanding queries prior to formal site closure
  • RA & QA Collaboration: Prepare document packages for Regulatory Affairs (for EC and IRB submissions), track protocol amendments and ICFs, and conduct periodic gap analyses of eTMFs to maintain a constant state of audit readiness
  • System & Logistics Facilitation: Manage site and monitor access to critical trial systems (EDC, IRT, and eTMF) and assist in organizing documentation for SIVs and investigator meetings
  • Cross-Trial Process Optimization: Maintain central monitoring dashboards to provide Project Managers with real-time visibility into open action items and study compliance metrics

Education
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field

Main Requirements
  • 2+ years of hands-on experience in clinical research (CRO or pharma). Experience as a Field CRA, In-house CRA, or Study Startup Specialist is strongly preferred
  • Understanding of Good Clinical Laboratory Practice (GCLP) and Good Documentation Practices (GDP) is required
  • Familiarity with oncology protocols and their associated high-volume documentation (frequent amendments, complex lab kits, and staff logs)
  • Experience navigating eTMF systems (e.g., Veeva Vault) and CTMS platforms
  • Professional fluency in English is mandatory
  • Strong organizational skills, keen attention to detail, and a proactive, solution-oriented approach

Working Conditions
  • Full-time position requiring 100% onsite attendance

What We Can Offer
  • Competitive wages ($55,400 - $73,800 USD)
  • Medical, dental, and vision benefits
  • 401(k) retirement savings plan with a healthy match
  • Vacation and sick time
  • Employee Assistance Program (EAP)
  • Referral Program

About CellCarta
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!
Join us as we make an impact on patient therapy!
The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, "CellCarta"). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.
CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [email protected].