Local Study Associate Director
On-site · Karnataka, India
Job Summary
Lead country-level delivery of studies, guiding Local Study Teams (CRAs/CSAs) to achieve on-time, on-budget delivery with high-quality data and inspection readiness. Collaborate with Global Study Teams, sites, investigators and local stakeholders to translate strategy into action, accelerate recruitment, ensure data quality, and support regulatory submissions. Responsible for feasibility assessments, site strategy and visits, EC/IRB submissions, budgeting and financial stewardship, CTMS/eTMF and local systems, monitoring oversight from activation to closeout, risk management and escalation, regular Local Study Team meetings, and cross-functional collaboration with Medical Affairs. Drive recruitment strategies, investigator engagement, and national investigator meetings; ensure adherence to ICH-GCP and local regulations; coordinate with Regulatory Affairs on authority submissions; manage country-level budgets and payments; maintain an inspection-ready eTMF and lead audits/regulatory inspections; coach and develop new team members and promote continuous process improvement. Desirable experience includes multi-therapeutic area exposure, prior CRA/Lead CRA roles, and data-driven risk-based monitoring.
Required Qualifications
- Ownership of country-level study delivery with on-time, on-budget, high-quality outcomes
- Leadership of Local Study Teams of CRAs/CSAs and other contributors
- Deep knowledge of ICH-GCP, local regulations and company procedures
- Experience conducting clinical and operational feasibility assessments
- Site strategy including Site Qualification Visits and quality risk assessment
- Experience coordinating EC/IRB applications and regulatory submissions with Regulatory Affairs
- Proficiency in CTMS, eTMF and related study finance platforms
- Experience overseeing monitoring from activation to closeout and guiding monitors
- Co-monitoring and accompanied site visits for quality and consistency
- Risk management with development of country-level risk plans and escalation
- Structured team meetings, transparent communication and stakeholder engagement
- Experience contributing to patient recruitment strategies and investigator engagement
- Forecasting study timelines, resource needs, recruitment, budgeting, and product supply
- Knowledge of Safety Reporting, Regulatory Submission and Clinical Trial Transparency systems
- Training new team members in ICH-GCP and company procedures
- Maintaining inspection-ready eTMF and coordinating audits/inspections
- Commitment to local policies, ethics, and continuous process improvement
- Collaboration with Medical Affairs and cross-functional study management and monitoring
- Willingness to engage in site monitoring as part of a flexible capacity model
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