Position Summary:

We are seeking an experienced Clinical Trial Operations Consultant to provide strategic and hands-on support in the planning, execution, and oversight of clinical trials. The ideal candidate will possess strong project management skills, a deep understanding of clinical trial processes, and the ability to work cross-functionally with internal teams and external partners. This role is critical in ensuring operational excellence, regulatory compliance, and timely delivery of milestones across global clinical studies.

Key Responsibilities

• Lead and manage the end-to-end execution of clinical trials (Phase I-IV), including study planning, start-up, conduct, and close-out activities.
• Collaborate with cross-functional teams (Regulatory, Medical, Data Management, Quality, Safety, etc.) to align operational strategies with overall clinical development goals.
• Develop, implement, and maintain project plans, timelines, risk management strategies, and trial budgets.
• Monitor study performance metrics, track deliverables, and drive resolution of study issues to ensure quality and compliance.
• Oversee vendor selection, contract negotiations, and performance management (CROs, labs, eClinical vendors, etc.).
• Ensure trial conduct aligns with ICH-GCP, regulatory requirements, and SOPs.
• Support the preparation of study documents, including protocols, investigator brochures, ICFs, study plans, and regulatory submissions.
• Conduct feasibility assessments, site qualification, and initiation activities.
• Provide leadership and mentorship to study teams, CRAs, and site monitors when applicable.
• Contribute to process improvement initiatives and the development of clinical operations best practices.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum of 7+ years of experience in clinical trial operations and 3+ years in project/study management.
• Proven track record of managing complex, global clinical studies across multiple therapeutic areas.
• In-depth knowledge of ICH-GCP guidelines, FDA/EMA regulations, and industry best practices.
• Experience with clinical trial management systems (CTMS), electronic data capture (EDC), eTMF, and other eClinical tools.
• Strong organizational, analytical, and problem-solving skills.
• Excellent interpersonal and communication skills, with the ability to influence cross-functional teams and vendors.
• PMP or similar project management certification is a plus.
• Experience working in a fast-paced, entrepreneurial environment or consulting role preferred.

Why Join Us

• Engage with innovative and transformative clinical research programs
• Work alongside passionate professionals committed to advancing healthcare
• Flexible working arrangements and a collaborative, growth-oriented culture

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