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Clinical Study Startup Manager Jobs in Indiana (NOW HIRING)

Becton, Dickinson and Company

Study & Site Management * Serve as CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and closeout activities (onsite, virtual, remote)

MediSphere Medical Research Center, LLC

Be Seen First

Clinical Research Assistant II

Evansville, IN · On-site

... Management * Accurately complete source documentation during participant visits. * Enter study data ... Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard ...

micro1 AI

Medical Writing Manager

Fishers, IN · Remote

$50 - $80/hr

Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs ... and appendix management. * Evaluate scientific accuracy in narrative sections such as efficacy ...

micro1 AI

Medical Writing Manager

Evansville, IN · Remote

$50 - $80/hr

Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs ... and appendix management. * Evaluate scientific accuracy in narrative sections such as efficacy ...

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Clinical Study Startup Manager information

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 Indiana?

The most popular types of Clinical Study Startup jobs in Indiana are:

What are popular job titles related to Clinical Study Startup Manager jobs in Indiana?

For Clinical Study Startup Manager jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Clinical Study Startup Manager jobs in Indiana look for?

The top searched job categories for Clinical Study Startup Manager jobs in Indiana are:

What cities in Indiana are hiring for Clinical Study Startup Manager jobs?

Cities in Indiana with the most Clinical Study Startup Manager job openings:

Clinical Study Startup Manager jobs near you

Senior Global Clinical Study Manager

IQVIA

Indianapolis, IN

Full-time

Re-posted 27 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 53 frontline employees who took The Breakroom Quiz

62nd of 224 rated it services

Job description

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Drive global clinical trials from first site activation to final patient visit-own the strategy, accelerate delivery, and shape the future of clinical research worldwide.

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
  • Ability to work across multiple therapeutic areas
Job Overview

We are seeking a Global Study Manager responsible for the end-to-end planning, execution, and delivery of clinical trial site management activities across global studies. This role ensures successful site selection, activation, monitoring oversight, and closeout-while balancing speed, quality, and cost. You will serve as the primary point of contact for clients, lead cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols. This is a highly visible role that combines strategic leadership, operational execution, and financial oversight.

Key ResponsibilitiesGlobal Study & Site Leadership
  • Lead site management strategy from study award through close-out
  • Oversee site identification, selection, activation, and recruitment performance
  • Ensure clinical monitoring processes meet study needs and timelines
  • Partner with CRAs to optimize enrollment, data quality, and compliance
Project & Stakeholder Management
  • Serve as primary client contact and own key customer relationships
  • Lead cross-functional teams across regions and cultures
  • Facilitate internal and external meetings, including executive presentations
  • Drive collaboration across stakeholders, vendors, and functional leads
Operational Excellence & Risk Management
  • Develop and manage integrated study plans and risk mitigation strategies
  • Proactively identify risks and implement corrective/preventative actions
  • Monitor study timelines, enrollment trends, and data quality metrics
  • Ensure compliance with GCP, SOPs, protocols, and regulatory standards
Financial & Contract Management
  • Manage study financials, including forecasting and revenue acceleration
  • Identify and manage out-of-scope work and change orders
  • Oversee Billing Unit Reviews (BURs) and expense approvals
  • Track performance against budget and Estimate at Completion (EAC)
Quality & Compliance
  • Maintain TMF health and ensure timely document submission
  • Develop quality monitoring plans and compliance metrics
  • Ensure adherence to study tools, training materials, and processes
Team Leadership & Development
  • Lead and mentor cross-functional project teams
  • Support CRA and team training on therapeutic areas and study-specific needs
  • Foster collaboration, knowledge sharing, and continuous improvement
QualificationsRequired
  • Bachelor's degree in life sciences or related field
  • 5+ years of clinical research/monitoring experience, including 2 years in a clinical study management role
  • Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
  • Experience managing global clinical trials and multi-regional teams
  • Demonstrated experience in project financial management
Core Competencies
  • Exceptional communication and stakeholder management skills
  • Strong problem-solving and risk mitigation capabilities
  • Ability to influence without authority in matrix organizations
  • High attention to detail and quality-driven mindset
  • Proficiency in Microsoft Office and clinical systems (e.g., CTMS, EDC)
Why Join Us
  • Work on cutting-edge global trials across therapeutic areas
  • Collaborate with top talent in a dynamic, global environment
  • Make a direct impact on patient outcomes worldwide

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

What IQVIA employees say

Pay

Benefits

Hours and flexibility

Workplace

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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US

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