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.
PXL FSP is seeking an experienced eCOA Technical Project Manager to join our team in a hybrid capacity based in Rahway, NJ. This role will serve as a key liaison between clinical, technology, and external eCOA vendors, ensuring the successful planning, implementation, and delivery of eCOA solutions across clinical trials. The ideal candidate brings a strong blend of technical expertise, clinical trial knowledge, and project leadership to support high‑quality, compliant digital data collection initiatives.
Description of Role & Responsibilities
• Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
• Defines/redesigns COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities.
• Creates and enforces the use of COA systems standards. Responsibilities may include creation / revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
• Performs peer-review of the COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.)
• Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and client performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
• Serves as project manager of all COA systems activities for protocols assigned.
• Uses interpersonal, negotiating, and project management skills to perform the following tasks:
o Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IRT & COA systems related issues and end of study vendor deliverables.
o Activity definition and sequencing, duration estimation, schedule development, and schedule control.
o Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
o Communication planning, information distribution, performance reporting, and project closure.
• Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
• Provides support for successful integration of client and vendor systems.
• Provides support for problem resolution between COA vendors and client’s Clinical Trial Team.
• May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
• May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
• May mentor new staff.
• May lead a continuous improvement special project or any other project or perform any other COA related task deemed appropriate by management.
Minimum FTE Years of Experience
• Minimum of 3 years’ experience in eCOA Project Management
• Able to read and interpret clinical trial protocols
• Effective Verbal and Written Communication Skills
• Attention to detail
• Stakeholder engagement and collaboration experience
• Cross functional collaboration
• Ability to adapt in a fast-paced environment
• Risk management experience
• Familiarity working with Microsoft Project
• 2 days a week in the client office required
Educational Requirements
• B.A. or B.S. degree in Computer Science, Biology, or a related discipline
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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.
Top Skills
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.
