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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.
The Global Site Start-up (SSU) Lead is accountable for the global execution of site activation for assigned clinical trials, performing responsibilities with moderate oversight. The Global SSU Lead is accountable for ensuring site start-up is efficient, timely and in accordance with the sponsor 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 to ongoing process improvement initiatives.
CORE JOB RESPONSIBILITIES:
Site Start-up Strategy
- Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and 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 and actively mitigating and escalating risks cross functionally.
- Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
- Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.
- Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).
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 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 package, 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 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 team to ensure timely SSU issue resolution
Process Improvement
- Recommends and participates in cross functional and department process improvements.
- May require up to 25% travel
Skills
- Demonstrates 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
- 4-6 years of experience
Skills Required
- Demonstrated interpersonal & leadership skills
- Ability to understand and implement operational strategic direction for 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 team 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)
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Effective project management skills, cross-functional team interaction and organizational skills
- 4-6 years of experience
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.
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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.
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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.
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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
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.
