Venisha Hoskins

Provide enterprise-level leadership and operational oversight of clinical monitoring teams supporting complex biotech sponsor portfolios.

• Served as Functional Area Lead for Gilead and Biogen partnerships, delivering governance oversight and monitoring performance leadership
• Led workforce planning and study coverage across multiple programs while maintaining utilization targets
• Improved TMF timeliness and quality through structured root cause analysis and accountability alignment initiatives
• Strengthened inspection readiness through proactive documentation review and targeted training reinforcement
• Developed and mentored clinical monitoring professionals, supporting progression from ACRA to CRA and into CTM, CTL, Project Leadership, Regulatory Affairs, and People Manager roles
• Established the North America Clinical Manager Mentor Program (2020) to advance leadership readiness
• Managed escalation pathways and operational risk mitigation with sponsor and internal stakeholders
• Partnered with Data Management and Safety teams to support database lock and study close-out activities
• Ensured compliance with subject privacy, confidentiality, and regulatory requirements
• Monitored evolving clinical trial methodologies and regulatory expectations to inform operational practices
• Collaborated with Pharmacovigilance on safety reporting oversight and issue escalation

Provided leadership oversight of clinical monitoring professionals across active clinical programs supporting biotech sponsors.

• Managed CRA utilization, performance metrics, and compliance alignment with ICH-GCP and regulatory requirements
• Guided CRAs in identifying site process failures and developing corrective and preventative action (CAPA) plans
• Supported monitoring governance and operational risk mitigation with study leadership
• Contributed to development of the Hematology/Oncology Academy core curriculum to standardize monitoring training
• Led onboarding, coaching, and performance development of clinical monitoring staff
• Partnered with cross-functional teams to address site issues and maintain study timelines

Supported oversight of clinical monitoring staff and study execution across assigned clinical programs.

• Coached CRAs on monitoring expectations, compliance standards, and site management practices
• Reviewed monitoring documentation for quality and adherence to SOPs and regulatory requirements
• Partnered with study teams to identify performance risks and implement corrective actions
• Assisted with resource planning and coverage management across active studies
• Supported onboarding and development of new clinical monitoring staff
• Reinforced inspection readiness through ongoing training and compliance monitoring

Served as Lead CRA across global Phase II/III metabolic liver disease clinical trials.

• Coordinated monitoring strategy and site oversight across assigned investigator sites
• Served as primary resource for CRAs, providing guidance on protocol adherence and issue resolution
• Reviewed monitoring documentation to ensure quality and regulatory compliance
• Identified site risks and supported corrective actions to maintain study timelines and compliance
• Partnered with study leadership to support audit readiness and inspection preparedness

Conducted monitoring activities across global Phase II/III metabolic liver disease clinical trials.

• Independently managed investigator site relationships and monitoring oversight
• Ensured protocol compliance, data integrity, and subject safety across assigned sites
• Identified and escalated site risks to support timely resolution
• Supported audit readiness through proactive documentation review and follow-up

Monitored global Phase II Parkinson’s Disease clinical trials within a multicenter environment.

• Managed investigator site oversight to ensure protocol compliance, data integrity, and subject safety
• Identified and escalated site risks to support timely resolution and maintain study timelines
• Maintained regulatory alignment through proactive documentation review and follow-up
• Collaborated with study team members to support consistent trial execution

Conducted monitoring activities for Parkinson’s Disease clinical trials.

• Ensured protocol compliance, subject safety, and data integrity across assigned sites
• Supported consistent study execution through collaboration with study teams
• Escalated site issues to support timely resolution

Supported Phase III Nephrology (CKD/Dialysis), Endocrinology (Diabetes), and HPV vaccine clinical trials.

• Performed monitoring activities ensuring regulatory compliance and site performance
• Followed up on site findings and supported audit readiness

Supported monitoring activities within multicenter clinical trials.

• Maintained regulatory compliance and documentation accuracy
• Developed investigator site communication and study coordination experience

• Coordinated regulatory documentation and tracking to support monitoring readiness
• Partnered with CRAs to prepare sites for study visits and compliance reviews

• Facilitated IRB submissions and site activation readiness
• Supported contract and budget coordination processes

• Prepared regulatory documentation and maintained start-up tracking systems
• Supported site communication and activation timelines

Supported regulatory documentation and clinical study tracking systems.

Coordinated patient visits and data collection for longitudinal schizophrenia clinical research studies in both inpatient and outpatient settings.

• Conducted subject screening, recruitment, informed consent, and follow-up visits
• Performed clinical assessments, interviews, and neurocognitive testing per protocol
• Collected and documented laboratory specimens and clinical data in case report forms
• Maintained source documentation and prepared reports for regulatory and study oversight purposes
• Tracked patient eligibility through record review, databases, and physician referrals