Description
Responsibilities:
- Lead operational execution of assigned clinical trials under both:
- In-house managed models (direct CRA/site oversight), and
- Outsourced models (full-service or functional CRO partnerships)
- Ensure consistent application of sponsor SOPs regardless of delivery model
- Drive study start-up, enrollment, and close-out milestones across all regions
- Directly manage CRAs and/or Lead CRAs assigned to in-house managed studies
- Provide functional oversight of IHCRAs - Assign, prioritize, and track IHCRA work activities, including:
o Site document review and tracking
o Remote monitoring support and follow-up
o Query and action item tracking
o TMF/eTMF filing support and completeness checks
- Review IHCRA outputs for quality, timeliness, and compliance
- Provide feedback, coaching, and training input to IHCRAs in collaboration with line managers
- Assign sites, review monitoring plans, and ensure adequate site coverage
- Review monitoring visit reports, follow-up letters, and issue resolution
- Coach and mentor CRAs to ensure monitoring quality and compliance
- Provide sponsor oversight of CROs, vendors, and functional service providers
- Review and approve CRO deliverables (monitoring plans, reports, metrics, TMF status)
- Ensure CRO performance aligns with contracted scope, KPIs, timelines, and quality standards
- Lead governance meetings, performance reviews, and escalation management
- Ensure clear documentation of sponsor oversight activities per ICH E6(R2/R3)
- Experience supporting and overseeing both Risk-Based Monitoring (RBM) strategies and traditional 100% SDV monitoring models, as appropriate to study design, risk profile, and regulatory expectations
- Ability to transition studies between RBM and 100% SDV approaches based on protocol requirements, inspection feedback, or sponsor risk assessments
- Oversight of monitoring plans to ensure:
o Appropriate SDV/SDR levels
o Centralized monitoring outputs are reviewed and actioned
o On-site, remote, and hybrid monitoring approaches are appropriately applied
- Oversee protocol deviations, CAPAs, and quality issues
- Identify operational risks early and implement mitigation strategies
- Act as escalation point for complex site, CRA, or CRO issues
- Partner with sites to support enrollment, retention, and protocol adherence
- Ensure studies are inspection-ready at all times
- Support and participate in regulatory inspections and audits (FDA, EMA, Health Authorities)
- Ensure timely TMF completeness and eTMF oversight (in-house and CRO-maintained TMFs)
- Collaborate with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, and Supply Chain
- Provide operational input into protocols, ICFs, feasibility, and country/site strategy
- Support investigator meetings, site trainings, and study communications
- Provide regular study status updates to senior management
- Maintain oversight trackers, risk logs, issue logs, and KPI dashboards
- Ensure accurate documentation of decisions, deviations, and actions
- Any other duties as assigned by Supervisor.
Requirements
Qualifications
Education
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (required)
- Advanced degree preferred
Experience
· 8+ years of clinical research experience, including management of both in-house and outsourced trials, with 6+ years of onsite monitoring CRA experience, including people management and CRO oversight exposure
- Experience managing global or multi-regional Phase I–III trials preferred
Core Competencies & Skills
- Strong understanding of sponsor oversight responsibilities under ICH-GCP
- Hands-on experience with both direct CRA management and CRO governance
- Expertise in RBM, centralized monitoring, and quality risk management
- Strong leadership, communication, and stakeholder management skills
- Ability to manage multiple studies and vendors simultaneously
- Proficiency with CTMS, eTMF, and clinical systems
Preferred Experience
- Sponsor-side experience in biotech or pharmaceutical companies
- Experience transitioning studies between in-house and outsourced models
- Experience in complex or rare disease trials
- Prior inspection support experience
Travel
Up to 60% travel- Focused on co-monitoring, audit readiness visits, CRO oversight visits, inspections
Skills Required
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
- Advanced degree
- 8+ years clinical research experience including management of in-house and outsourced trials
- 6+ years onsite monitoring CRA experience with people management and CRO oversight exposure
- Experience managing global or multi-regional Phase I-III trials
- Strong understanding of sponsor oversight responsibilities under ICH-GCP
- Hands-on experience with direct CRA management and CRO governance
- Expertise in Risk-Based Monitoring (RBM), centralized monitoring, and quality risk management
- Proficiency with CTMS, eTMF, and clinical systems
- Strong leadership, communication, and stakeholder management skills
- Ability to manage multiple studies and vendors simultaneously
- Experience transitioning studies between in-house and outsourced models
- Experience in complex or rare disease trials
- Prior inspection support experience (FDA, EMA, other Health Authorities)
- Willingness/ability to travel up to 60% for co-monitoring, audits, CRO oversight, and inspections
What We Do
Zydus Therapeutics is a clinical-stage, specialty-focused bio-pharmaceutical company dedicated to developing transformative treatments to improve lives. The company focuses on unlocking new possibilities in life sciences and providing quality healthcare solutions, with an initial focus on treating rare and serious liver diseases and anemias. As a subsidiary of Zydus Lifesciences, it leverages extensive R&D and manufacturing capabilities to discover new medicines.
