Clinical Study Specialist
Primary Location: United States, Remote Job ID R0000035915 Category Project Leadership Date Posted 10/07/2025Overview
As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.
In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Collaborative
- Leadership
- Proactive
- Problem-solver
About This Role
PXL has an exciting opportunity for a Clinical Study Specialist!
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
CSS Duties
- Organizes and delivers analyzable reports and metrics to the clinical study lead
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
- Collates data for assessments such as feasibility and site selection and reviews site usability database
- Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
- Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
- Collates materials for training and investigator meetings
- Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
- Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
- Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
- Supports receipt of scheduled reports (i.e. 1572 reportable changes, financial disclosure form)
- Manages and maintains team SharePoint and/or shared drive sites, as needed
- Communication with sites as directed and maintains site contact information
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- May manage or contribute to oversight of Third Party Vendors (TPV)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Proactively recommends process improvement initiatives for the department
- May require 25% travel
CSS requirements
- Bachelor’s degree (or equivalent) and a minimum of 2+ years’ industry related work experience or an advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work preferred.
- Attention to details for the ability to track information and deliver on assigned study activities
- Good communication and interpersonal skills; ability to build relationships internally and externally
- Ability to be resourceful and to demonstrate problem solving skills
- Demonstrate the ability to proactively assess information and investigate impact on clinical trials
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Basic familiarity with medical terms and clinical drug development
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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 United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Potential Career Path
Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.
- Associate Project Leader
- Project Leader
- Senior Project Leader
- Associate Project Director
- Project Director
- Director, Project Leadership
- Senior Director, Project Leadership
Employee Insights
Why Project Leaders work at Parexel
