

New · posted Nov 4
Regeneron · Biotechnology
Manager, Global Study Start-Up
- Armonk, NY
- On-site
- Full-time
- Manager
The role
Build our future together
The Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight to ensure efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. Partnering closely with cross-functional teams and Clinical Research Organizations (CROs), this role balances strategic oversight with hands-on leadership to address challenges and deliver study objectives. The SSU Lead develops site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics. Additionally, they lead all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision-making.
What you need
This role requires
· Demonstrated interpersonal & leadership skills
· Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
· A data driven approach to planning, executing, and problem solving
· Effective communication skills via verbal, written and presentation abilities
· Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
· Ability to influence and negotiate across key stakeholders
· Ability to build productive study teams collaborations
· Experience in the clinical drug development process, with expertise in study start-up
· Demonstrated vendor management experience
· Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel
· Knowledge of ICH/GCP and regulatory guidelines/directives
· Effective project management skills, cross-functional team interaction and organizational skills
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.
What you'll do
Site Start-Up Strategy
- Develop the site start-up strategy for each study, outlining all dependencies impacting site activation while actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics — including risks and mitigation strategies — to evaluate CRO performance and implement corrective actions.
- Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
- Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
- Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
Country Start-Up
- Partner with cross-functional and CRO partners (where applicable) to develop a comprehensive global country start-up strategy, outlining all dependencies impacting country start-up while actively mitigating and escalating risks cross-functionally.
- Monitor and maintain country intelligence data to support informed decision-making and develop accurate start-up projections and strategic plans.
- Support regulatory submissions as needed, including:
- Providing required site documentation
- Coordinating submissions to Central Institutional Review Boards (CIRBs)
- Supporting sites with Local Institutional Review Board (LIRB) submissions
- Handling or supervising Clinical Research Organization (CRO) insurance requests
- Ensure timely country submission deliverables (task completion, role clarity, identification of critical path items, and effective communication pathways).
Site Start-Up Management
- Lead and oversee all aspects of site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
- Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing.
- Oversee CRO site start-up management or the in-house site-facing regional SSU team, where applicable.
- Lead the collection and analysis of site intelligence to support strategic site selection and site start-up.
- Oversee the preparation and approval of site regulatory packages, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
Team Interactions
- Represent Site Start-Up (SSU) on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues.
- Act as the escalation point for CRO and internal teams to ensure timely SSU issue resolution.
Process Improvement
- Recommend and participate in cross-functional and departmental process improvements.
Pay and benefits
$114,800 – $187,400 a year
Employer provided$114,800.00 - $187,400.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Armonk, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Armonk, NYWorking conditions
Travel
- May require up to 25% travel
When & where
- Primary Location: Armonk, NY
- Additional Locations: Warren, NJ
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Clinical Operations roles at this level.
This roleEmployer provided
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $114,800 | — | $187,400 |
| All US (middle half) | $150,000 | $154,500 | $161,250 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 104 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- Clinical trial conduct15
- Documentation and SOPs6
- GMP and compliance4
- Regulatory submissions3
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigationsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Regeneron on Regulatory Jobs
- 169
- Open roles
- 144
- Distinct roles
- 11
- Locations
By discipline
- Clinical71 42%
- Quality70 41%
- Regulatory28 17%
By level
- Associate & Specialist56 33%
- Director50 30%
- Manager48 28%
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Manager, Global Study Start-Up at Regeneron
Open until filled. $115K–$187K a year, employer provided.

