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Global Study Manager Jobs in Delaware (NOW HIRING)

Hologic

Sr Manager, Regulatory Operations

Newark, DE · On-site

This role ensures global compliance with regulatory requirements while enabling efficient, scalable ... Updates job knowledge by studying trends and developments in Regulatory and Quality. Qualifications:

Qps Llc

Pharmacovigilance Safety Manager

Newark, DE · On-site

$100 - $130/hr

Pharmacovigilance Safety Manager Full Time Regular Sr Professiona-Other Newark, DE, US 7 days ago ... global safety guidance * Working knowledge of safety reporting requirements within clinical studies

Global Talent Partners Veterinary

Veterinarian

Newark, DE · On-site

$120 - $140/hr

Veterinarian J892245 Newark Delaware USD120K- USD140K / Year Global Talent Partners is delighted to ... Opportunities to participate in clinical studies * Employee pet discounts * Mental health and ...

New

Joyson Safety Systems

We are a global leader in design, development and manufacturing of safety-critical systems and ... Carry out parameter studies, design of experiment or topology studies for component & systems ...

410 ICR United States USA

TMF Specialist

Wilmington, DE

$33.75 - $45.25/hr

TMF Specialist ICON is a global healthcare intelligence and clinical research organisation united ... record management activities, study closure, archival and retention. The role supports the ...

New

410 ICR United States USA

TMF Specialist

Wilmington, DE

$33.75 - $45.25/hr

TMF Specialist ICON is a global healthcare intelligence and clinical research organisation united ... record management activities, study closure, archival and retention. The role supports the ...

New

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All JobsGlobal Study JobsGlobal Study Manager JobsGlobal Study Manager Jobs in Delaware

Global Study Manager information

See Delaware salary details

$23K

$61.4K

$102.6K

How much do global study manager jobs pay per year?

As of Sep 5, 2026, the average yearly pay for global study manager in Delaware is $61,404.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $69,100.00 per year, depending on experience, location, and employer.

How does a global study manager collaborate with cross-functional teams during a clinical trial?

A Global Study Manager plays a pivotal role in coordinating with cross-functional teams, such as clinical operations, data management, regulatory affairs, and safety teams, to ensure smooth execution of clinical trials. They facilitate regular meetings, provide clear communication on study timelines and deliverables, and address any issues that arise across different geographic regions. Effective collaboration is crucial for aligning global processes, maintaining data consistency, and meeting regulatory requirements, making strong interpersonal and project management skills essential for success in this role.

What are the key skills and qualifications needed to thrive as a global study manager, and why are they important?

To excel as a Global Study Manager, you need expertise in clinical trial management, regulatory requirements, and project leadership, often backed by a life sciences degree and experience in global studies. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and GCP certification are commonly required. Excellent organizational skills, cross-cultural communication, and problem-solving abilities are vital soft skills for this role. These skills ensure effective coordination of international studies, compliance with regulations, and the successful delivery of complex clinical projects.

What does a global study manager do?

A global study manager oversees the planning, execution, and management of clinical research studies across multiple regions or countries. They coordinate with cross-functional teams, ensure compliance with regulatory requirements, and monitor study progress using project management tools to meet deadlines and quality standards.

What are popular job titles related to Global Study Manager jobs in Delaware?

For Global Study Manager jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Global Study Manager jobs in Delaware look for?

The top searched job categories for Global Study Manager jobs in Delaware are:

What cities in Delaware are hiring for Global Study Manager jobs?

Cities in Delaware with the most Global Study Manager job openings:

Global Study Manager jobs near you
Infographic showing various Global Study Manager job openings in Delaware as of August 2026, with employment types broken down into 85% Full Time, 13% Part Time, and 2% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $61,404 per year, or $29.5 per hour.

Sr Manager, Regulatory Operations

Hologic

Newark, DE • On-site

Full-time

Posted 12 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

181st of 499 rated machine equipment manufacturers

Job description


Job Summary:
The Senior Manager, Regulatory Operations provides strategic and operational leadership to ensure compliant, efficient and scalable regulatory processes. This role is responsible for key regulatory operational areas including labeling, post-market regulatory reporting, state licensing and regulatory agency account maintenance, and Unique Device Identification (UDI) governance. This role ensures global compliance with regulatory requirements while enabling efficient, scalable processes that support a growing medical device portfolio. Provides counsel to and manages the regulatory team. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Establishes operational objectives and work plans, and delegates assignments to subordinate managers. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect. Manages activities of two or more sections of departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
  • Serve as the Divisional labeling process owner and ensure compliance with global labeling requirements (FDA, EU, and other international regulations). Oversee end-to-end labeling processes, including development, review, approval, and lifecycle management of product labeling.
  • Establish and maintain labeling procedures, systems, and controls to ensure accuracy, consistency, and traceability and manage external vendors for translations. Partner with Quality and Commercial teams to support timely product launches, updates, and changes.
  • Lead regulatory post-market summary reporting activities including managing timely submission of reports to regulatory authorities (i.e., Periodic Safety Update Report, Health Canada summary report)
  • Manage regulatory establishment registrations and device listings, oversee US state licensing requirements and maintain regulatory data integrity within external databases including FURLS and Eudamed.
  • Serve as process owner for UDI compliance and governance across global markets. Oversee UDI data creation, validation, and submission to regulatory databases (e.g., GUDID, Eudamed).
  • Leads global standards management process and drives cross-functional collaboration with R&D, Quality, Clinical, and Manufacturing teams to identify, assess, and implement applicable international and regional medical device standards (e.g., ISO, IEC, FDA-recognized); ensures effective communication of requirements, alignment on compliance strategies, and integration of standards into product development and lifecycle processes
  • Develop, implement and maintain procedures and processes for regulatory operations
  • Responsible for planning, assigning, and directing work, performance management, facilitating employee development, mentoring and coaching to maximize engagement and productivity. Directs activities as well as sets goals and objectives for the Regulatory function.
  • Updates job knowledge by studying trends and developments in Regulatory and Quality.

Qualifications:
Education
  • Preferred Minimum Non-Technical Degree: BA/BS Degree
  • Preferred Minimum Technical/Advanced Degree: Master's Degree

Experience
  • Preferred Minimum Non-Technical Degree: 10+ Years
  • Preferred Minimum Technical/Advanced Degree: 7+ Years with Master's Degree, 5+ Years with PhD

Skills
  • Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, EU MDD/MDR regulations and relevant global regulations related to medical devices.
  • Strong knowledge in medical device labeling requirements and previous experience leading a labeling function preferred
  • Computer literate; able to use word processing, spreadsheet programs, databases.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
  • Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors, and all levels of employees.
  • Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role.
  • Demonstrated success in management role.
  • Ability to work effectively in a strongly matrixed team-oriented structure.
  • Excellent communication, interpersonal and relationship management skills
  • Experience in medical device, pharmaceutical or equivalent regulated industry
  • QA and/or RA certification is beneficial.

Ready to make a difference in women's health? Apply today and join our team of passionate innovators at Hologic!
Additional Info:
The annualized base salary range for this role is $145,000 to $241,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms, or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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