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.
Parexel FSP has an exciting opportunity for a candidate with strong experience in Clinical Study Startup!
Essential Functions
Trial Start Up Group
- Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.
- Laser focus approach to oversight of start up activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful execution.
- Accountable for all matters related to CRO partners study start-up requirements and must be able to communicate issues effectively CRO counterpart and colleagues (eg CTM) as required.
- Adopting a unique start-up methodology to drive site activations through oversight of all activities, driving delivery and compliance across the assigned regions and CRO partners
- Leads day to day project activities in the matrix, by working closely with the Clinical Trial Manager and CRO counterparts.
- Oversees start up activities with one or more CRO partners at a program and/or study level
- Acting as a Senior Manager with regional colleagues co-ordinate regional information to present based on oversight of regional colleagues (if required) depending on size of study/complexity.
- Evaluate performance and solve acute challenges and monitor timelines and progress vs. plan
- Specialist knowledge of start-up requirements & activities in each country and region, country requirements, inner workings of a country/ regulatory landscape.
- Works collaboratively with functional colleagues to ensure successful completion of study start up, fostering productive working relationships with other collaborators within Regulatory, Legal, Contracts and Clinical Operations
- Reviews program or study specifics to define project scope, timelines, and deliverables from project initiation and maintains/monitors throughout
- Reviews and approves start up plan(s) that clarify study specific tasks, general timelines, and processes related to overall study start up.
- Liaise with other project team members to ensure cohesive and clear project performance and expectation
Required Knowledge, Skills, and Abilities
- Extensive pharmaceutical or related industry experience
- Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials.
- Experience in project management, CRO experience, change management or process design are beneficial
- The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.
- Excellent knowledge of GCP and regulations
- Experience of controlled drug substances processed would be beneficial
- Experience of developing junior members of staff would be beneficial
- Experience of Regulatory Inspections
Required/Preferred Education and Licenses
- Degree (BSc) or equivalent experience gained through time in industry (>5yrs)
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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
- Extensive pharmaceutical or related industry experience
- Extensive experience working in study start-up, as Clinical Trial Specialist, CRA, or Clinical Trial Manager on global trials
- Specialist knowledge of country and regional start-up requirements and regulatory landscapes
- Good working knowledge of clinical operations, clinical processes, and medical terminology
- Excellent knowledge of GCP and relevant regulations
- Experience of regulatory inspections
- Degree (BSc) or equivalent experience (>5 years)
- CRO experience, project management, change management, or process design
- Experience handling controlled drug substances processed
- Experience developing junior staff
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.
