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.

Application Link

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