Description
Lead and direct the clinical research portfolio, setting strategy and overseeing the design, activation, and execution of multi-site studies. Ensure regulatory compliance, subject safety, data integrity, and fiscal stewardship. Manage cross-functional teams, vendors, and partnerships; establish policies, quality systems, and performance metrics; and communicate results to leadership, sponsors, and regulators.
- • Secure and prioritize a portfolio of industry- and investigator-initiated trials through strategic partnerships and business development.
- • Monitor scientific, regulatory, and market trends; represent the program at conferences and professional forums.
- • Oversee trial registration and site activation processes (e.g., ClinicalTrials.gov, IRB approvals) across studies.
- • Lead audit readiness and host sponsor, FDA, and institutional audits; implement CAPA plans.
- • Build, negotiate, and manage program and study budgets, contracts, and financial forecasts.
- • Set clinical operations standards; ensure adequate staffing, training, and resources for protocol execution.
- • Provide governance for protocol adherence and safety oversight in collaboration with principal investigators.
- • Approve recruitment strategies and patient engagement materials to ensure ethical and brand compliance.
- • Select and govern vendors, technology, and equipment platforms (e.g., EDC, CTMS, eConsent) to meet study needs.
- • Convene cross-functional teams to optimize recruitment and retention across sites; track performance KPIs.
- • Review portfolio enrollment, retention, and cycle-time metrics; lead remediation and acceleration plans.
- • Chair feasibility and protocol review committees to assess operational, ethical, and financial viability.
- • Oversee safety management systems and serious adverse event reporting; liaise with DSMBs and pharmacovigilance.
- • Approve study documentation and SOPs; ensure timely IRB submissions, continuing reviews, and renewals.
- • Guide protocol design and operational strategies, aligning endpoints, schedules, and data plans with feasibility.
- • Establish, train, and audit informed consent processes for GCP and HIPAA compliance.
- • Oversee investigational product and device supply chains, accountability, and reconciliation with pharmacy/biomed.
- • Plan and allocate research space, infrastructure, and capital to support current and future studies.
- • Lead governance with sponsors and CROs; resolve escalations and oversee site visit cadence and reporting.
- • Develop and sustain training, credentialing, and competency programs for research staff and investigators.
- • Approve patient-facing communications and lay summaries; ensure health literacy and cultural appropriateness.
- • Direct risk management, deviation trend analysis, and root-cause investigations; approve protocol amendments and CAPA.
- • Set policies for dispensing and dose management; ensure pharmacy and device handling SOP compliance.
- • Govern biospecimen lifecycle management, including consent, chain of custody, and laboratory/vendor agreements.
- • Ensure robust follow-up and data completeness plans, integrating EHR and registry data where appropriate.
- • Oversee laboratory data reconciliation, data review meetings, and query management processes.
- • Sponsor publication and dissemination strategies; review and approve abstracts, posters, and manuscripts.
- • Establish data quality governance with biostatistics and data management; ensure timely database locks.
- • Define and audit eligibility verification procedures, including central review where applicable.
- • Approve site selection, portfolio resource allocation, and capacity-building initiatives.
- • Implement scheduling standards and digital tools to streamline participant visits and procedures.
- • Establish QA/QC frameworks, monitoring plans, and compliance audits to ensure GCP, FDA, and institutional policy adherence.
- • Ensure complete and inspection-ready TMF/CTMF and regulatory documentation across the portfolio.
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Last reviewed: Jan 2026
