Site Activation Leader

Posted 8 Days Ago
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Hiring Remotely in United States
Remote
Senior level
Pharmaceutical
The Role
Leads clinical trial site activation from feasibility through initiation, managing critical paths, regulatory and ethics requirements, documentation, timelines, risks, systems, and cross-functional teams. Serves as a client-facing subject matter expert, guides activation staff, oversees quality and compliance, analyzes metrics, improves processes, and supports proposals and business development across multiple studies and therapeutic areas.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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. 

 

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! 

 

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. 

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.

Skills Required

  • 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
  • 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
  • Understanding of clinical trial timelines and milestone management
  • Excellent written and verbal communication skills with senior stakeholders

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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