Note: The job is a remote job and is open to candidates in USA. Immunic Therapeutics is seeking a Clinical Study Lead to provide operational leadership for the planning and execution of global clinical studies or assigned regions. The role coordinates cross-functional teams, investigative sites, CROs, and vendors while managing timelines, budgets, quality, risks, compliance, and study close-out activities.
Responsibilities
- Provide operational leadership for the planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions, ensuring delivery against approved scope, timelines, quality standards, and budget
- Serve as the principal Clinical Operations representative on cross-functional study teams and associated sub-teams, clearly communicating operational status, risks, assumptions, dependencies, and recommendations
- Develop, review, and maintain integrated study execution plans, regional and country strategies, enrollment plans, oversight plans, monitoring plans, study manuals, and operational trackers
- Contribute operational input to protocols, informed consent forms, eCRFs, investigator materials, clinical study reports, and other critical study documents
- Lead or oversee country and site feasibility, site identification, qualification, selection, activation, training, enrollment, maintenance, and close-out activities for the assigned scope
- Contribute to CRO and vendor selection and oversight activities, including scope definition, contracting support, performance expectations, governance, issue resolution, change control, invoice review, and reconciliation
- Monitor study and vendor performance through meaningful KPIs, quality indicators, milestones, forecasts, and dashboards; implement corrective actions and escalate material issues in a timely manner
- Identify operational, quality, timeline, budget, and compliance risks; maintain mitigation plans and coordinate resolution with the Global Clinical Study Lead and cross-functional stakeholders
- Provide accurate inputs to study timelines, budgets, accruals, resource forecasts, enrollment forecasts, clinical supply forecasts, and scenario planning activities
- Coordinate regional or country-level investigator meetings, site communications, training, and engagement activities in partnership with relevant internal and external stakeholders
- Ensure sponsor oversight activities are documented and inspection-ready, including appropriate management of the eTMF, essential documents, monitoring deliverables, deviations, CAPAs, and study correspondence
- Ensure timely completion of database-lock readiness, document reconciliation, site and vendor closure, final payments, archiving, and delivery of Clinical Operations content for the clinical study report and appendices
- Support audits, inspections, and health-authority interactions by providing complete, accurate, and traceable operational documentation and responses
- Provide technical guidance, coaching, and mentoring to junior Clinical Operations team members and contribute to departmental standards, tools, and process improvements
- Act as back-up for the Global Clinical Study Lead or other study leadership roles as assigned
Skills
- Bachelor's degree or higher in nursing, life sciences, health sciences, or a related discipline; an equivalent combination of education and relevant clinical research experience may be considered
- Typically 7+ years of pharmaceutical, biotechnology, or CRO experience, including at least 6 years of clinical research experience with increasing responsibility
- Demonstrated experience managing Phase 1-3 clinical studies or substantial regional components from start-up through close-out and clinical study report delivery
- Experience working in a fully or substantially outsourced operating model, including selection, contracting, oversight, and performance management of CROs and specialist vendors
- Strong working knowledge of ICH-GCP, applicable FDA, EMA, and local regulatory requirements, sponsor oversight expectations, inspection readiness, and clinical quality management principles
- Proven ability to manage complex timelines, budgets, risks, priorities, and cross-functional dependencies in a global matrix organization
- Strong analytical, organizational, and problem-solving skills, with consistent attention to detail and a proactive, accountable working style
- Excellent written and verbal communication skills in English, with the ability to influence internal and external stakeholders across cultures and levels of seniority
- Ability to work effectively and independently in a dynamic, flexible, and innovative environment while managing multiple responsibilities under pressure
- Willingness and ability to travel domestically and internationally based on study needs
Benefits
- Offers Equity
- Offers Bonus
- Remote work arrangement
Company Overview