Clinical Operations Manager
Zydus Therapeutics Inc., Trenton, NJ, United States
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:
Site document review and tracking
Remote monitoring support and follow‑up
Query and action item tracking
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:
Appropriate SDV/SDR levels
Centralized monitoring outputs are reviewed and actioned
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
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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:
Site document review and tracking
Remote monitoring support and follow‑up
Query and action item tracking
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:
Appropriate SDV/SDR levels
Centralized monitoring outputs are reviewed and actioned
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
#J-18808-Ljbffr