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:
Monitoring and Management of Investigator Sites
• Conducts source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion
• Identifies issues that may impact on the conduct of the study and ensure appropriate closure of all issues
• Proactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met
• Ensures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs) and procedures
• Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements
• Informs the Principal Investigator (PI) and site staff of all issues
• Agrees and develops corrective and preventative actions with PI and site personnel to close all open issues
• Responsible for all aspects of site management from collaboration on site selection to study closeout
• Trains site staff on the protocol, protocol amendments and Client processes
• Understands the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team
• Interacts with health care professionals in a manner, which enhances Client’s credibility with the customer
Data Quality
• Ensures that data monitored meets target quality standards
• Ensures that data is entered into Client systems in a timely manner
Reporting
• Reports on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred
• Ensures all issues are correctly identified and catalogued
• Proactively manages issues to appropriate closure
• Maintains accurate site-level information on corporate clinical trials registry
Documentation
• Obtains critical information to enable generation of Investigator Initiation Package (IIP) documentation
• Assists Clinical Trial Assistant (CTA) in gathering IIP documentation where required to ensure timely site set up
• Maintains the Site Master File (SMF) and SMF log
• Ensures Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurate
• QC relevant documents in ELARA and/or TMF in a timely manner
• Generates site monitoring reports
• Maintains all appropriate monitoring logs
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:
• Computer Literacy (word processing and spreadsheets, PowerPoint)
• Proficient in Chinese, good command of written and spoken English is required
• Good interpersonal skills, good at communication
• A flexible attitude with respect to work assignments and new learning, quickly-learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
Knowledge and Experience:
• At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience, global study monitoring experience is preferred
• Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research
Education:
• Degree in Life Science, Nursing, Pharmacy, or other relevant education background
• Bachelor’s degree or above, or equivalent
Skills Required
- At least 1.5 years of Clinical Monitoring/Site Management experience
- Good knowledge of ICH/GCP, relevant regulations
- Degree in Life Science, Nursing, Pharmacy or relevant
- Proficient in Chinese, good command of English
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.
