Associate Director, Clinical Study Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership for operational planning, initiation, execution, maintenance, and closure of designated global studies or regions.

• Act as the primary Clinical Operations representative on cross-functional study teams and sub-teams.

• Communicate updates regarding operational status, risks, assumptions, dependencies, and recommendations.

• Develop, review, and uphold study execution plans, regional and country strategies, enrollment plans, oversight plans, monitoring plans, study manuals, and operational trackers.

• Contribute operational insights to protocols, informed consent documents, eCRFs, investigator materials, clinical study reports, and additional study documentation.

• Lead or supervise the feasibility, identification, qualification, selection, activation, training, enrollment, maintenance, and closure of countries and sites.

• Assist in CRO and vendor selection and oversight, including defining scope, supporting contracting, governance, resolving issues, managing change control, and reviewing and reconciling invoices.

• Monitor study and vendor performance utilizing KPIs, quality indicators, milestones, forecasts, and dashboards; enact corrective measures and escalate significant concerns.

• Identify and address operational, quality, timeline, budget, and compliance risks.

• Provide input for timelines, budgets, accruals, resource forecasts, enrollment forecasts, clinical supply forecasts, and scenario planning.

• Coordinate investigator meetings, site communications, training, and engagement activities.

• Ensure that sponsor oversight documentation is inspection-ready, including eTMF, essential documents, monitoring deliverables, deviations, CAPAs, and study correspondence.

• Guarantee database-lock readiness, document reconciliation, site and vendor closure, final payments, archiving, and Clinical Operations content for clinical study reports and appendices.

• Support audits, inspections, and interactions with health authorities.

• Offer technical guidance, coaching, and mentoring to junior Clinical Operations team members.

• Contribute to the development of departmental standards, tools, and process enhancements.

• Serve as backup for the Global Clinical Study Lead or other leadership positions within studies.

⛳️ Requirements

• Bachelor’s degree or higher in nursing, life sciences, health sciences, or a related field; equivalent education and relevant clinical research experience may be accepted.

• Generally, 7+ years of experience in pharmaceuticals, biotechnology, or CRO settings.

• Minimum of 6 years of clinical research experience with escalating responsibilities.

• Proven experience managing Phase 1-3 clinical studies or significant regional components from initiation through closure and clinical study report completion.

• Familiarity with a fully or predominantly outsourced operating model, including CRO and specialist vendor selection, contracting, oversight, and performance management.

• Strong understanding of ICH-GCP, FDA, EMA, and local regulatory requirements.

• Awareness of sponsor oversight expectations, inspection readiness, and clinical quality management principles.

• Capability to manage complex timelines, budgets, risks, priorities, and cross-functional dependencies within a global matrix organization.

• Excellent analytical, organizational, and problem-solving abilities.

• Proficient written and verbal communication skills in English.

• Ability to work autonomously in a dynamic, flexible, and innovative setting while handling multiple responsibilities under pressure.

• Willingness and capability to travel domestically and internationally as required by study needs.

• Must possess authorization to work in the US.

🏝️ Benefits

• Equity.

• Bonus.

• Remote work arrangement.

• Opportunity to collaborate with global clinical operations teams.