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Clinical Study Startup Manager Jobs in Indiana (NOW HIRING)

micro1 AI

Medical Billing Specialist

South Bend, 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 Billing Specialist

Carmel, 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 Billing Specialist

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 Billing Specialist

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 ...

micro1 AI

Medical Billing Specialist

Fort Wayne, 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 Billing Specialist

Indianapolis, 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

Project Lead Data Manager

Elanco Animal Health Incorporated

Indianapolis, IN • On-site

$49.50 - $67/hr

Full-time

Retirement, PTO

Re-posted 14 days ago

Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

50th of 86 rated pharmaceutical

Job description

At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role:
Project Lead Data Manager
As a Project Lead Data Manager, you will serve as a technical authority and strategic leader in achieving our global clinical data management objectives. In this role, you will be responsible for advancing the end-to-end technical lifecycle of clinical studies, ensuring that data capture, management, and archival processes are executed with precision across both electronic and paper-based systems. By collaborating closely with cross-functional partners in Clinical Development, Biostatistics, and Regulatory Affairs, you will guide data management strategies that result in the on-target delivery of submission-ready databases, ensuring all deliverables meet rigorous quality standards and are fully compliant with regulatory requirements and Good Clinical Practice (GxP) guidelines.
Your Responsibilities:
  • Lead the end-to-end technical lifecycle of clinical data management for assigned projects, from initial Case Report Form (CRF) design and database build to final database lock and archival.

  • Author and maintain comprehensive Study Data Management Plans (DMPs) and Data Validation Specifications (DVS) to ensure alignment with study protocols and regulatory requirements.

  • Drive data integrity through robust data cleaning strategies and ensure all technical Data Management (DM) activities are validated and executed against regulatory requirements (including Good Clinical Practice - GxP) and internal SOPs.

  • Manage technical deliverables from Contract Research Organizations (CROs) and third-party vendors, ensuring adherence to Elanco's quality standards and project timelines.

  • Educate and advocate for Data Management (DM) policies and procedures with both internal and external stakeholders.

  • Coach and mentor junior Data Management colleagues, fostering a positive and collaborative team environment.

What You Need to Succeed (minimum qualifications):
  • Education: Bachelor's degree (BS) or equivalent in a scientific field, or relevant work experience in animal health or a related industry.

  • Experience: A minimum of 5 years in Clinical Data Management, with proven experience supporting global Research & Development (R&D) initiatives.

  • Leadership & Adaptability: Demonstrated leadership skills with the ability to work effectively within interdisciplinary teams, showing high levels of adaptability, flexibility, and learning agility in a fast-paced environment.

Technical Skills:
  • EDC & Database Lifecycle: Advanced proficiency in Electronic Data Capture (EDC) platforms and a thorough understanding of the clinical database development lifecycle, including design, User Acceptance Testing (UAT), and lock procedures.

  • Data Management Documentation: Proven ability to author and manage essential Data Management (DM) documents, including Data Management Plans (DMPs) and Data Validation Specifications (DVS).

  • Data Quality: Expertise in data cleaning methodologies, query management, and the oversight of data integrity within a Good Clinical Practice (GxP) environment.

What will give you a competitive edge (preferred qualifications):
  • Direct experience with clinical trial data for regulatory authority submissions (e.g., FDA, EMA).

  • Advanced knowledge of modern Electronic Data Capture (EDC) systems and data visualization tools.

  • Previous experience in clinical study monitoring or formal project management.

Additional Information:
  • Travel: 10% or less on an annual basis.

  • Location: This is a hybrid role based at our Global Elanco Headquarters in Indianapolis, IN.

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
  • Multiple relocation packages

  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)

  • 8-week parental leave

  • 9 Employee Resource Groups

  • Annual bonus offering

  • Flexible work arrangements

  • Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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