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.
Job Summary:
The Clinical Trial Specialist (CTS) is responsible for assisting with study management of assigned projects in accordance with SOPs, Good Clinical Practice (GCP), International Conference of Harmonization (ICH) guidelines and local regulations. Study management activities may include maintenance of information databases and trial tracking reports, coordination of clinical trial documentation and general support to ensure the successful and timely execution of clinical activities and deliverables.
Key Accountabilities:
Develop, organize and maintain tracking systems and tools across multiple programs to support efficient execution, oversight and compliance of a clinical study from start-up to closeout
Coordinate and lead the development, review and maintenance of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, coordinate and distribute meeting agendas, minutes, and follow-up action items for study teams.
Establish, manage and oversee study files and shared spaces to ensure accuracy, accessibility and compliance
Manage documentation of study training to ensure compliance
Manage study sample and supply accountability and develop collaborative relationships with vendor teams.
Partner with the study management team to Lead or manage specific projects as appropriate.
Serve as a key point of contact for study team members, facilitating effective communication and proactive resolution of study challenges
Conduct and oversee quality control reviews of trial-level documents ensuring compliance with study procedures and regulatory requirements
Ensure timely, complete and compliant archiving of the TMF in accordance with study and regulatory
Actively participate in and contributes to company, departmental and project team meetings including Investigator Meetings, providing input and updates as appropriate
Familiar with and assist in maintaining clinical invoice tracking and other budget databases for projects, generate periodic reports on status of payments and resolve payment inquiries from investigator sites
Requirements:
BS/BA degree or degree in healthcare scientific field required
Minimum of 2+ years of experience in clinical operations within a biopharmaceutical company or 3+ years experience in a CRO environment with increasing responsibilities for independent study support
Strong knowledge of drug development and clinical operations processes
Applies working knowledge of clinical trial processes and regulatory requirements to independently support study execution in compliance with ICH/GCP and Code of Federal Regulations
Excellent written and verbal communication skills, effectively collaborating with study teams and site, CRO staff and vendors
Strong organization and interpersonal skills
Proficiency using eTMF systems to support inspection readiness
Strong attention to detail and consistency in document quality, compliance and completeness
Ability to prioritize and manage multiple tasks and competing deadlines in a fast-paced study environment
Proactively identify, investigate and resolve routine issues while effectively managing deadlines
High sense of urgency and strong time management skills, independently managing workloads across multiple studies
Proficient with MS Office Suite (Excel, Word, PowerPoint) with ability to independently develop reports and presentations
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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.
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.
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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.
