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 de…
Skills: Program Management, Line Management, Clinical Operations, Resource Management, KPI Tracking
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 de…
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 de…
Skills: Trial Design, Protocol Development, Analysis Planning, Regulatory Submissions, SAS
Scientist III - Analytical Chemist Drug Product - FSP
New Jersey, United States · On-site
Mid level
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 de…
Director, Data Product Coordination Lead (Data & Technology)
Southport, North Carolina, United States · Remote OK
Senior+
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 de…
Skills: Strategic Leadership, Data Operations, Stakeholder Management, Executive Communication, Data Governance
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 de…
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 de…
Skills: Research Design, Analytical Strategies, Statistical Analysis Plans, Quality Control, SAS
Global Clinical Operations Leader / Clinical Trial Manager
Raleigh, North Carolina, United States · Remote OK
Senior
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 de…
Skills: Clinical Operations Strategy, Global Clinical Trial Management, Study Startup, Site Selection, Risk Mitigation
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 de…
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 de…
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 de…
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 de…
Senior eClinical Business Lead, IRT & DHT Design Consultant
Bengaluru, Karnataka, India · Remote OK
Senior
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 de…
Skills: RTSM Design, DHT Design, User Requirements Gathering, User Acceptance Testing, CDISC SDTM
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 de…
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 de…
Skills: Consulting, Critical Thinking, Problem Solving, Project Leadership, Project Management
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 de…
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 de…
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 de…
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 de…
Skills: Analytical Thinking, Critical Thinking, Attention To Detail, Problem Solving, Time Management
Clinical Research Associate (CRA II/Senior) - Bilingual French/English
Quebec, Quebec, Canada · Remote OK
Mid level
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 de…
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Full-time
bachelor degree
Posted 16d ago
~40 hrs/week
Responsibilities
The role involves managing FSP Clinical Operations programs and serving as the primary point of contact between senior management and clients. It also includes line management of staff, overseeing resource utilization, and ensuring compliance with regulatory standards.
Requirements
Requires a minimum of 4+ years of clinical operations experience and a Bachelor's degree or equivalent. Candidates should have comprehensive knowledge of FDA/local regulations and ICH/GCP guidelines.
Full job description
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.
Key Accountabilities:
Program Management
May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities
May serve as a liaison to one or more Clients
May be responsible for Program Management activities related to one or more programs:
May assist with the implementation, management, and closeout of Client programs, as required
May develop interview tools and conduct interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input)
Evaluates and deploys resources based on Client need, experience, and availability (workload capacity management, contingency planning), and manages/analyzes resource utilization to ensure cost effectiveness
May lead/contribute to Client-specific Operations meetings with Operations internal staff o Manages program issues, including problem identification, resolution, and escalation, as appropriate to FSP Clinical Operations and Client
Proactively manages program-level expectations, Key Performance Indicators (KPIs), and metrics
Oversees program transitions to ensure proper training, adequate project support, and to ensure the resource is aware of program expectations
Utilizes tools and systems to proactively collect, track, and analyze compliance/performance metrics
Adheres to quality standards and timelines within assigned areas in compliance with local regulations (i.e., FDA, EMA, etc.), ICH/GCPs, and SOPs
Line Management
Manages FSP Clinical Operations assigned staff dependent upon Client structure and services
Oversees/Manages personnel and administrative issues for assigned FSP Clinical Operations staff (direct reports):
Provides staff with appropriate orientation, integration, guidance, and training on Client and FSP Clinical Operations systems and processes
Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required)
Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution, coaching/mentoring of assigned staff, and escalation as appropriate to FSP Clinical Operations and Client
Supports and promotes staff professional development; assesses and provides opportunities for soft skills development
Conducts one on one meetings with direct reports, based on program requirements
Reviews and approves time and expenses in the applicable Time Management System
Conducts annual and ad hoc performance evaluations for all direct reports, as applicable
Hires, retains and develops a skilled, experienced, and motivated team o Minimizes regrettable turnover
Supports implementation of retention strategies for assigned staff
Oversees onboarding and offboarding of staff, as applicable
Reviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staff
Oversees training compliance of staff related to SOPs, systems, and processes
Serves as a key communication liaison between FSP Clinical Operations Management and staff
Collaboration
Interacts closely with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, etc.), as well as Client representatives, depending upon scope of services and structure
Collaborates with Quality to ensure adherence to ICH/GCP guidelines
Observes, collects, and analyzes FSP Clinical Operational issues to discuss with/resolve on behalf of FSP Clinical Operations management
Assists FSP Clinical Operations management with program/projects as necessary
May collaborate with interdepartmental functions to create business proposals including Request for Information/Request for Proposals (RFI/RFPs) to meet each Client’s specifications
Supports efforts to identify opportunities for increased quality and efficiency
Compliance with Parexel Standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Ability to motivate direct reports
Effective interpersonal and communication skills, both written and verbal
Self-motivated, detail-oriented, and flexible
Well-developed planning, observation, prioritization, analytical, and problem-solving skills
Demonstrated independent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativity
Strong computer skills with MS-Office products such as, but not limited to, Excel, Word, and PowerPoint
Proficient in written and spoken English required
Proficient in local language (as applicable), preferred
Knowledge and Experience:
Minimum 4+ years of clinical operations experience; demonstrated leadership, coaching or mentoring experience preferred; FSP Clinical Operations experience preferred
Comprehensive knowledge of FDA and/or local regulations and ICH/GCP guidelines, and strong working knowledge of the drug development process and clinical trial operations
Previous experience working in a remote office environment and managing remote staff preferred
Education:
Bachelor’s Degree or equivalent, or other required experience confirmed to be equivalent during the hiring process
Parexel is a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award.
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.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Regulatory and product development consultingearly phase clinical researchphase II-III clinical researchlate phase clinical researcheClinical solutionspatient and site recruitmentmedical device consultingclinical research organizationpharmacovigilancebiotechnology
Parexel is a leading global clinical development partner providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award.
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.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Regulatory and product development consultingearly phase clinical researchphase II-III clinical researchlate phase clinical researcheClinical solutionspatient and site recruitmentmedical device consultingclinical research organizationpharmacovigilancebiotechnology