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Clinical Study Start Up Director Jobs (NOW HIRING)

CEDENT

Study Start-Up Manager

Wilmington, DE

Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · On-site

Working across clinical operations, sites, and strategy, you will remove obstacles, compress ... Partner closely with CRAs and the Local Study Team/Local Study Associate Director to achieve start ...

Alnylam Pharmaceuticals

Sr. Manager, Study Start Up

The Senior Manager, Study Start-up partners closely with the Clinical Operations study team leading ... The Senior Manager, Study Start-up provides direct oversight, direction, and support beginning with ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · On-site

Working across clinical operations, sites, and strategy, you will remove obstacles, compress ... Partner closely with CRAs and the Local Study Team/Local Study Associate Director to achieve start ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · On-site

Working across clinical operations, sites, and strategy, you will remove obstacles, compress ... Partner closely with CRAs and the Local Study Team/Local Study Associate Director to achieve start ...

Glaukos

Manager Study Start-up

San Clemente, CA · On-site

Lead the operational execution of clinical studies from start-up through close-out, including site ... direct or matrixed. * Strong working knowledge of FDA regulations, GCP, and global clinical ...

Glaukos

Manager Study Start-up

San Clemente, CA · On-site

What You'll Do: • Lead the operational execution of clinical studies from start-up through close ... direct or matrixed. * Strong working knowledge of FDA regulations, GCP, and global clinical ...

BeiGene, Inc.

Global Clinical Study Senior Manager

Study start-up strategy * Enrollment acceleration plans * Site activation timelines * Data flow and ... Clinical Operations (regional teams / RCSMs) * Medical, Regulatory, Biometrics, Supply, etc.

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Clinical Study Start Up Director information

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How much do clinical study start up director jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for clinical study start up director in the United States is $54.33, according to ZipRecruiter salary data. Most workers in this role earn between $32.45 and $71.63 per hour, depending on experience, location, and employer.

What does a clinical study start up director do?

A Clinical Study Start Up Director oversees and coordinates all activities required to initiate clinical trials at research sites. This includes managing regulatory submissions, negotiating site contracts, ensuring compliance with local and international regulations, and leading cross-functional teams to meet study timelines. Their role is crucial in minimizing delays, facilitating communication among stakeholders, and ensuring that studies are ready to enroll participants as efficiently as possible.

What are some common challenges faced by a clinical study start up director, and how can they be addressed?

A Clinical Study Start Up Director often encounters challenges such as navigating complex regulatory requirements, coordinating cross-functional teams, and managing tight timelines for study activation. Ensuring clear communication across stakeholders and proactively identifying potential regulatory or operational bottlenecks are key strategies for overcoming these hurdles. Building strong relationships with site staff, sponsors, and regulatory bodies also helps streamline processes and reduce delays, ultimately supporting successful and timely study launches.

What are the key skills and qualifications needed to thrive as a clinical study start up director, and why are they important?

To thrive as a Clinical Study Start Up Director, you need a deep understanding of clinical trials, regulatory requirements, project management, and typically a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic Trial Master Files (eTMF), and regulatory submission platforms is essential, along with certifications such as PMP or RAC being advantageous. Strong leadership, strategic thinking, and excellent communication skills help drive cross-functional teams and manage complex timelines. These skills are crucial to ensure studies launch efficiently, compliantly, and on schedule, directly impacting the success of clinical research programs.

What is the difference between Clinical Study Start Up Director vs Clinical Trial Coordinator?

AspectClinical Study Start Up DirectorClinical Trial Coordinator
ResponsibilitiesOversees study initiation, regulatory submissions, site selection, and start-up processesAssists with site coordination, patient recruitment, and data collection during trials
Required CredentialsTypically advanced degrees (e.g., MS, PhD), experience in clinical research, regulatory knowledgeBachelor’s degree, certification in clinical research (e.g., CCRP), entry-level experience
Work EnvironmentStrategic planning, cross-department collaboration, high-level oversightOn-site or remote coordination, direct interaction with sites and patients

The Clinical Study Start Up Director focuses on the strategic and regulatory aspects of initiating clinical trials, requiring extensive experience and advanced credentials. In contrast, the Clinical Trial Coordinator handles day-to-day trial activities, site communication, and patient management. Both roles are essential but differ in scope, responsibilities, and experience levels.

What are the most commonly searched types of Clinical Study Start Up jobs?

The most popular types of Clinical Study Start Up jobs are:

What are popular job titles related to Clinical Study Start Up Director jobs?

For Clinical Study Start Up Director jobs, the most frequently searched job titles are:

Infographic showing various Clinical Study Start Up Director job openings in the United States as of September 2026, with employment types broken down into 94% Full Time, 5% Part Time, and 1% Contract. Highlights an 67% In-person, 7% Hybrid, and 26% Remote job distribution, with an average salary of $113,010 per year, or $54.3 per hour.

Study Start-Up Manager

Wilmington, DE

CEDENT
IT Services • 11 - 50 employees
Learn more about CEDENTexternal

Full-time

Re-posted 16 days ago

Job description

Summary

We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site management, and expertise in ensuring compliance with local and international guidelines, particularly ICH-GCP.
 

Key Responsibilities
  • Lead and manage start-up activities for clinical studies, ensuring compliance with local and international guidelines (ICH-GCP).
  • Prepare, review, and track site regulatory documentation throughout the study start-up phase.
  • Collaborate with Clinical Research Associates (CRAs) and the local study team to meet start-up milestones.
  • Participate in Local Study Team meetings and report on site performance metrics.
  • Ensure the timely submission of documents to regulatory authorities and maintain the trial master file (eTMF).

Qualifications
  • Minimum 3 years of experience in Clinical Study Start-Up (full-time).
  • At least 1 year of hands-on experience with Veeva Vault.
  • Strong background in informed consent review and negotiation.
  • Bachelor’s degree (higher degree preferred) with knowledge of clinical trial processes (Phases II-IV) and ICH-GCP.
  • Excellent communication, organizational, and project management skills.
  • Strong problem-solving and negotiation abilities.
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About Cedent

Sourced by ZipRecruiter

CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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