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Clinical Study Design Manager Jobs (NOW HIRING)

BIOTRONIK SE & Co.KG

$100 - $125/hr

Your Responsibilities Clinical Study Management & Execution * Participate in all phases of clinical investigations, including study design, initiation, enrollment, study execution, data analysis, and ...

Biotronik

Clinical Studies Engineer II

Lake Oswego, OR · On-site

Your Responsibilities Clinical Study Management & Execution * Participate in all phases of clinical investigations, including study design, initiation, enrollment, study execution, data analysis, and ...

RDI

Proposal Manager - Study Design

Los Angeles, CA · On-site

RDI designs and runs diagnostic clinical studies. Many of the opportunities we receive are not ... The requirements can be incomplete, assumptions can conflict, and the obvious study design is not ...

RDI

Proposal Manager - Study Design

Los Angeles, CA · On-site

RDI designs and runs diagnostic clinical studies. Many of the opportunities we receive are not ... The requirements can be incomplete, assumptions can conflict, and the obvious study design is not ...

Crio, Inc.

Study Design Specialist

$60K - $70K/yr

Our platform streamlines clinical data collection and management, ensuring protocol compliance and ... The Study Design Specialist is responsible for creating comprehensive study builds from start to ...

North American Science Associates, Inc.

$100 - $125/hr

Develops and maintains foundational study materials and tools (protocol with study design, training ... Supports internal clinical team members: protocol training, client and site management and ...

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Clinical Study Design Manager information

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$22K

$125.3K

$206K

How much do clinical study design manager jobs pay per year?

As of Sep 9, 2026, the average yearly pay for clinical study design manager in the United States is $125,290.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,000.00 and $157,000.00 per year, depending on experience, location, and employer.

What does a clinical study design manager do?

A Clinical Study Design Manager is responsible for planning and overseeing the design of clinical trials to ensure they are scientifically sound, ethical, and compliant with regulatory standards. They collaborate with cross-functional teams to develop study protocols, determine study objectives, and select appropriate methodologies. Their role also includes managing timelines, budgets, and ensuring the quality of data collected. Ultimately, they play a crucial part in advancing medical research by ensuring studies are set up for success.

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

To thrive as a Clinical Study Design Manager, you need a strong background in life sciences, experience in clinical research, and often an advanced degree such as an MS, MPH, or PhD. Familiarity with clinical trial management systems (CTMS), statistical analysis software, and knowledge of regulatory guidelines like GCP and ICH are typically required. Excellent project management, leadership, and cross-functional communication skills distinguish top performers in this role. These competencies ensure the efficient design, execution, and oversight of clinical studies that meet regulatory standards and scientific objectives.

What are some common challenges faced by clinical study design managers when coordinating cross-functional teams during the planning phase of a clinical trial?

Clinical Study Design Managers often encounter challenges in aligning the priorities and timelines of cross-functional teams, such as clinical operations, biostatistics, regulatory affairs, and medical writing. Ensuring clear communication and maintaining a cohesive strategy across these diverse groups is essential to prevent delays and ensure protocol feasibility. Additionally, balancing scientific integrity with regulatory requirements and operational constraints requires proactive problem-solving and strong negotiation skills. Successful managers foster collaboration by facilitating regular meetings, leveraging project management tools, and encouraging open dialogue among stakeholders.

What is the difference between Clinical Study Design Manager vs Clinical Research Associate?

AspectClinical Study Design ManagerClinical Research Associate
CredentialsTypically requires a master's degree in life sciences or related field; relevant certifications like CCRP or SOCRA are commonOften holds a bachelor's degree in life sciences; certifications like CCRP or RAC are advantageous
Work EnvironmentLeads study design, planning, and protocol development; works closely with cross-functional teamsMonitors clinical trials at sites; ensures compliance and data integrity
Industry UsageUsed in planning and overseeing clinical studies from inception to completionPrimarily involved in site monitoring and data collection during trials

The Clinical Study Design Manager focuses on designing and planning clinical studies, ensuring protocols meet scientific and regulatory standards. In contrast, the Clinical Research Associate is more involved in monitoring ongoing trials at clinical sites to ensure compliance and data quality. Both roles are essential in the clinical research process but differ in scope and responsibilities.

What are popular job titles related to Clinical Study Design Manager jobs?

For Clinical Study Design Manager jobs, the most frequently searched job titles are:

Infographic showing various Clinical Study Design Manager job openings in the United States as of July 2026, with employment types broken down into 3% As Needed, 72% Full Time, 18% Part Time, and 7% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $125,290 per year, or $60.2 per hour.

Manager Clinical Study Lead

Tarrytown, NY • On-site

Regeneron Pharmaceuticals, Inc.
Biotechnology Research and Development • 5 - 10K employees
Learn more about Regeneron Pharmaceuticals, Inc.external

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 12 days ago

Regeneron rating

8.5

Company rating: 8.5 out of 10

Based on 44 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical

Job description

Build our future together:
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.
When & where:
  • Work Location: Armonk, NY, Warren, NJ
  • 25% Travel may be required

Discover your role:
  • Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions
  • Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution
  • Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials
  • Oversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements
  • Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work
  • Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies
  • Leads study-level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan; and monitors data entry and query resolution against agreed metrics
  • Manages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study-level lessons learned
  • Assigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs
  • May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring

This role requires:
  • Bachelor's degree and have at least six years of relevant industry experience
  • Extensive budget management expertise; a proven ability to build productive study teams and collaborations; and demonstrated vendor management experience
  • Strong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC
  • Experience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives; and effective project management, cross-functional team leadership, and organizational skills
  • Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$128,600.00 - $210,000.00

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