Parexel is a leading global provider of biopharmaceutical services, dedicated to improving world health. Our expertise spans clinical trials, regulatory consulting, and market access, ensuring that every development solution contributes to life-saving therapies. At Parexel, we take pride in our commitment to excellence, empathy, and innovation, making a difference in patients’ lives every day.
Job Responsibilities
Start-up Phase (Site Identification to Pre-Initiation)
- Serve as the primary point of contact for assigned sites, ensuring quality and efficiency.
- Establish strong relationships with investigators and site staff.
- Conduct feasibility assessments and site qualification activities.
- Manage and negotiate Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA).
- Handle submission and approval processes for IRB/IEC and regulatory bodies.
- Ensure site activation, patient recruitment, and compliance with regulatory standards.
- Maintain accurate documentation and trial management systems.
Maintenance Phase (Initiation to Close-out)
- Act as Parexel’s direct contact with sites, ensuring study integrity and adherence.
- Conduct site visits, evaluate compliance, and resolve any site-related issues.
- Facilitate site access to study systems and ensure proper training.
- Monitor recruitment strategies, compliance, and data quality.
- Ensure sites are audit-ready and in line with ICH-GCP guidelines.
General Responsibilities
- Maintain and update Clinical Trial Management Systems (CTMS) regularly.
- Ensure timely completion of study goals and adherence to regulatory standards.
- Participate in audits, training programs, and inspections.
- Provide mentorship and training to team members.
- Work collaboratively in a matrix environment to achieve project objectives.
Required Qualifications
- Bachelor’s/Master’s degree in Biological Science, Pharmacy, or a related health discipline.
- Equivalent nursing qualification or significant experience in clinical research.
Required Skills
- Strong problem-solving and analytical skills.
- Ability to work independently and proactively seek guidance when needed.
- Excellent communication, presentation, and interpersonal skills.
- Proficiency in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office.
- Strong time management skills and the ability to multitask.
- Ability to work across different cultures and in a remote team environment.
- Willingness to travel as per project requirements.
