Study Startup Manager
Position Overview
We're looking for a highly motivated Clinical Operations Study Startup Manager to help accelerate study activation and drive early-stage execution across our dynamic clinical portfolio. This individual will own and optimize the study startup process—from site identification through activation—while building strong relationships with investigative sites and ensuring alignment across internal and external stakeholders.
• This is an ideal opportunity for someone who thrives in a fast-paced, small biotech environment, enjoys wearing multiple hats, and can operate with a high degree of independence while maintaining strong collaboration with sponsor teams, CRO partners, and legal stakeholders.
• Key Responsibilities: Lead Study Startup Execution
• Drive end-to-end startup activities, including feasibility, site selection, site activation, and study initiation
• Develop and maintain startup timelines to ensure aggressive enrollment targets are met
• Identify and proactively mitigate startup risks that could impact study timelines
• Site Relationship Development
• Build and maintain strong relationships with investigative sites, KOLs, and site staff
• Serve as a primary point of contact for sites during startup, ensuring engagement and responsiveness
• Support site readiness to enable rapid first patient in (FPI) and sustained enrollment momentum
• Enrollment & Timeline Delivery
• Partner cross-functionally to ensure startup strategies support enrollment goals
• Monitor site activation and early enrollment trends; adjust tactics as needed to stay on track
• Bring a solutions-oriented mindset to accelerate timelines in complex or competitive enrollment environments
• Cross-Functional Collaboration
• Work closely with Clinical Operations, Legal, Regulatory, and CRO partners to ensure efficient contract and budget negotiations
• Facilitate alignment between sponsor study teams and external vendors to remove bottlenecks
• Act as a key liaison between internal stakeholders and sites during startup
• Operational Agility & Problem Solving
• Operate as a utility player, stepping in across functions when needed to support study success
• Navigate ambiguity and shifting priorities with a proactive, ownership-driven mindset
• Continuously identify opportunities to improve startup processes, efficiency, and site experience
• Required Qualifications:
Bachelor’s degree in life sciences or related field
• 5+ years of clinical research experience, with direct ownership of study startup activities
• Demonstrated success in site selection, activation, and startup timeline delivery
• Proven ability to build and maintain strong site relationships
• Experience working closely with legal and study teams on contracts and startup deliverables
• Track record of meeting or accelerating enrollment timelines
• Experience in a small biotech or similarly fast-paced, resource-constrained environment
• Strong ability to work independently and manage competing priorities
• Preferred Qualifications:
Experience in oncology or early-phase clinical trials
• Experience in dermatology and/or immunology studies strongly preferred
• Prior experience working in both sponsor and CRO environments
• Familiarity with global study startup across multiple regions
• Strong understanding of regulatory and ethics submission processes (e.g., IRB/EC)
• Experience contributing to or improving startup strategy and site engagement models
• What Sets This Role Apart:
High-impact position with direct influence on study timelines and early execution success
• Opportunity to work in a nimble, growth-stage biotech environment where your voice matters
• Exposure to cross-functional leadership and strategic decision-making
• A role designed for individuals who thrive on ownership, autonomy, and problem-solving
Ideal Candidate Profile
You are someone who
• Moves quickly but thoughtfully, with a strong sense of urgency
• Builds trust easily with sites and internal stakeholders
• Anticipates problems before they arise—and solves them without waiting to be asked
• Is comfortable stepping outside defined roles to ensure team succes
Apply tot his job
Apply To this Job
We're looking for a highly motivated Clinical Operations Study Startup Manager to help accelerate study activation and drive early-stage execution across our dynamic clinical portfolio. This individual will own and optimize the study startup process—from site identification through activation—while building strong relationships with investigative sites and ensuring alignment across internal and external stakeholders.
• This is an ideal opportunity for someone who thrives in a fast-paced, small biotech environment, enjoys wearing multiple hats, and can operate with a high degree of independence while maintaining strong collaboration with sponsor teams, CRO partners, and legal stakeholders.
• Key Responsibilities: Lead Study Startup Execution
• Drive end-to-end startup activities, including feasibility, site selection, site activation, and study initiation
• Develop and maintain startup timelines to ensure aggressive enrollment targets are met
• Identify and proactively mitigate startup risks that could impact study timelines
• Site Relationship Development
• Build and maintain strong relationships with investigative sites, KOLs, and site staff
• Serve as a primary point of contact for sites during startup, ensuring engagement and responsiveness
• Support site readiness to enable rapid first patient in (FPI) and sustained enrollment momentum
• Enrollment & Timeline Delivery
• Partner cross-functionally to ensure startup strategies support enrollment goals
• Monitor site activation and early enrollment trends; adjust tactics as needed to stay on track
• Bring a solutions-oriented mindset to accelerate timelines in complex or competitive enrollment environments
• Cross-Functional Collaboration
• Work closely with Clinical Operations, Legal, Regulatory, and CRO partners to ensure efficient contract and budget negotiations
• Facilitate alignment between sponsor study teams and external vendors to remove bottlenecks
• Act as a key liaison between internal stakeholders and sites during startup
• Operational Agility & Problem Solving
• Operate as a utility player, stepping in across functions when needed to support study success
• Navigate ambiguity and shifting priorities with a proactive, ownership-driven mindset
• Continuously identify opportunities to improve startup processes, efficiency, and site experience
• Required Qualifications:
Bachelor’s degree in life sciences or related field
• 5+ years of clinical research experience, with direct ownership of study startup activities
• Demonstrated success in site selection, activation, and startup timeline delivery
• Proven ability to build and maintain strong site relationships
• Experience working closely with legal and study teams on contracts and startup deliverables
• Track record of meeting or accelerating enrollment timelines
• Experience in a small biotech or similarly fast-paced, resource-constrained environment
• Strong ability to work independently and manage competing priorities
• Preferred Qualifications:
Experience in oncology or early-phase clinical trials
• Experience in dermatology and/or immunology studies strongly preferred
• Prior experience working in both sponsor and CRO environments
• Familiarity with global study startup across multiple regions
• Strong understanding of regulatory and ethics submission processes (e.g., IRB/EC)
• Experience contributing to or improving startup strategy and site engagement models
• What Sets This Role Apart:
High-impact position with direct influence on study timelines and early execution success
• Opportunity to work in a nimble, growth-stage biotech environment where your voice matters
• Exposure to cross-functional leadership and strategic decision-making
• A role designed for individuals who thrive on ownership, autonomy, and problem-solving
Ideal Candidate Profile
You are someone who
• Moves quickly but thoughtfully, with a strong sense of urgency
• Builds trust easily with sites and internal stakeholders
• Anticipates problems before they arise—and solves them without waiting to be asked
• Is comfortable stepping outside defined roles to ensure team succes
Apply tot his job
Apply To this Job