Site Activation Leader

Parexel; Frankfort (KY); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation & Sick Time

Flexible Spending Account

Work/Life Balance

401(k) with company match

Pet Insurance

Job summary

Parexel is seeking a Site Activation Leader to join our remote-enabled team supporting multiple clinical studies. You will plan and manage site activation across feasibility, regulatory approvals, site initiation, activation, and study start-up in collaboration with PM, sites, and clients.

You will drive critical path development, monitor milestones, mitigate risks, and ensure compliant, high-quality site activation.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field.
• 4-7 years of experience in clinical research operations with site activation leadership.
• Proven experience leading site activation teams and processes.
• Comprehensive knowledge of clinical trial start-up processes and requirements.
• Strong background in regulatory compliance in clinical research.
• Extensive experience working with clinical research sites and investigators.
• Demonstrated understanding of clinical trial timelines and milestone management.
• Excellent written and verbal communication skills with senior stakeholders.

Responsibilities

• Lead site activation planning and strategy for assigned clinical studies.
• Develop, coordinate, and execute the study critical path plan, including site feasibility, site selection, regulatory steps, activation, and TMF management.
• Monitor and report site activation progress; identify delays and drive cross-functional solutions.
• Provide guidance to activation teams and liaise with PM, site activation, and clinical operations leadership.
• Manage client relationships and serve as the Study Start-Up SME for designated accounts.
• Assist business development with site activation expertise for proposals and bids.
• Implement standardized activation processes and drive quality initiatives.
• Ensure regulatory compliance and maintain activation procedures and templates.
• Lead the use of CTMS, EDC, IRT, and TMF systems to optimize activation workflows.
• Oversee documentation, data integrity, system maintenance, and resource allocation.

Skills

Site activation leadership

Strategic planning

Cross-functional coordination

Regulatory compliance

Stakeholder communication

Education

Bachelor's degree

Tools

CTMS

EDC

TMF systems

IRT

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.

About the Role

We are seeking a Site Activation Leader (Study Start-Up Lead, Site Start-Up Lead) to join our team working remotely.

As a Site Activation Leader, you will provide expert planning and functional oversight for clinical trial programs and individual studies, driving operational excellence and the on-time, high-quality initiation of clinical research sites. You will lead site activation activities from feasibility through activation, coordinate the study critical path, and help enable efficient study conduct and enrollment across multiple studies and therapeutic areas.

You will join a collaborative, growth-oriented environment where your leadership will connect project management, site start-up teams, clinical operations, clients, and investigative sites. Through strategic planning, cross-functional coordination, process optimization, and quality oversight, you will strengthen site activation delivery and contribute directly to the successful execution of clinical research.

Key Responsibilities

• Lead site activation planning and strategy development for assigned clinical studies, overseeing milestones and deliverables from site feasibility through last site activation.

• Develop, coordinate, and execute the study critical path plan, including site feasibility, site selection, Regulatory Green Light, site initiation, site activation, system setup, Trial Master File and Expected Document List management, ethics committee and regulatory authority or Ministry of Health strategy, informed consent form customization, risk mitigation, activation requirements, tools, documents, and reporting.

• Monitor and report site activation progress across multiple studies, identify potential delays and risks, and lead cross-functional teams in resolving complex activation challenges.

• Provide guidance to site activation team members and serve as a liaison among project management, site start-up teams, site activation functions, and clinical operations leadership.

• Manage client relationships and communications regarding site activation timelines and deliverables, and serve as the Study Start-Up Subject Matter Expert for designated client accounts.

• Provide strategic guidance, best practice recommendations, and technical expertise to support optimal study initiation and site activation outcomes.

• Support business development activities by contributing site activation expertise to proposals and bid pursuit meetings.

• Implement standardized site activation processes and best practices, analyze activation metrics, and drive process optimization and quality initiatives.

• Ensure compliance with regulatory requirements and company Standard Operating Procedures, and contribute to the development and maintenance of site activation procedures and templates.

• Lead the use of Clinical Trial Management System, Electronic Data Capture, Interactive Response Technology, and Trial Master File systems to optimize site activation workflows.

• Oversee accurate documentation, data integrity, system maintenance, timeline planning, and resource allocation across the assigned portfolio.

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in site activation leadership, strategic planning, and cross-functional coordination

• Comprehensive knowledge of clinical trial regulations, Good Clinical Practice, site activation processes, and clinical research operations

• Advanced project management, critical thinking, problem-solving, and process improvement capabilities

• The ability to communicate effectively with senior stakeholders, clients, investigative sites, and cross-functional teams

• Strong attention to detail and accuracy in complex clinical trial documentation

Required Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related field

• 4-7 years of experience in clinical research operations with site activation leadership

• Proven experience leading site activation teams and processes

• Comprehensive knowledge of clinical trial start-up processes and requirements

• Strong background in regulatory compliance in clinical research

• Extensive experience working with clinical research sites and investigators

• Demonstrated understanding of clinical trial timelines and milestone management

• Excellent written and verbal communication skills with senior stakeholders

Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits .

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.