Senior Clinical Study Lead

PRA HEALTH SCIENCES; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Ein führendes Unternehmen in der klinischen Forschung sucht einen Senior Clinical Study Lead, der die Verantwortung für die Leitung eines cross-funktionalen Teams übernimmt. In dieser spannenden Rolle sind Sie der Hauptansprechpartner für die Studienleitung und gewährleisten die Einhaltung von Vorschriften und Zeitplänen. Sie werden die Entwicklung von Studienprotokollen und Dokumentationen überwachen, die Budget- und Zeitplanung leiten und sicherstellen, dass alle Aspekte der klinischen Studien effizient und erfolgreich durchgeführt werden. Diese Position bietet Ihnen die Möglichkeit, in einem dynamischen Umfeld zu arbeiten und Ihre Fähigkeiten in der klinischen Forschung weiterzuentwickeln.

Benefits

Jährliche Urlaubsansprüche

Gesundheitsversicherungsoptionen

Altersvorsorge

Globale Mitarbeiterhilfe

Lebensversicherung

Flexible Vorteile wie Kinderbetreuungszuschüsse

Qualifications

• Mindestens 8 Jahre Erfahrung im Studienmanagement.
• Starke Fähigkeiten in der Führung und Kommunikation.
• Erfahrung im Budgetmanagement und in der Datenanalyse.

Responsibilities

• Leitung des cross-funktionalen Studienteams für die Studienlieferung.
• Überwachung der Entwicklung studienspezifischer Dokumentation.
• Management von CROs und Drittanbietern zur Sicherstellung der Lieferungen.

Skills

Studienmanagement

Interpersonelle Fähigkeiten

Führungskompetenz

Budgetmanagement

Datenanalyse

Verhandlungsgeschick

Projektmanagement

Kommunikationsfähigkeiten

Education

Bachelor-Abschluss in einem relevanten Bereich

Lizenzierter Gesundheitsberuf (z.B. Krankenschwester)

Tools

MS Office

CTMS

TMF

IVRS/IWRS

EDC

Job description

Overview

As a Senior Clinical Study Lead, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Lead the cross-functional study team responsible for clinical study delivery and serve as the primary contact for leadership and oversight for the assigned study.
• Provide operational input into protocol development.
• Oversee and contribute to the development of study-specific documentation, including CRFs, data management plans, monitoring plans, training plans, data review plans, and statistical analysis plans.
• Manage setup and maintenance of study systems like CTMS and TMF.
• Ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs, lead engagement, contracting, and management of vendors.
• Contribute to budget and timeline development and management.
• Lead risk assessments and develop mitigation strategies.
• Conduct feasibility assessments and oversee site evaluation and selection.
• Prepare and execute investigator meetings.
• Monitor site activation, visits, and deviations from plans.
• Develop and oversee patient recruitment and retention strategies.
• Monitor data entry, query resolution, and deviations from metrics.
• Ensure accurate budget management and scope changes.
• Oversee clinical supplies forecasting, drug accountability, and reconciliation.
• Escalate issues related to study conduct, quality, timelines, or budget and develop corrective actions.
• Oversee study execution against timelines, deliverables, and budget.
• Maintain data quality through regular reviews and ensure compliance with protocols and regulations.
• Manage CROs and third-party vendors to ensure scope delivery.
• Ensure readiness for audits and inspections, supporting CAPAs as needed.
• Manage study close-out activities, including database lock and documentation reconciliation.
• Contribute to study report writing and review.
• Facilitate lessons learned sessions.
• Assign tasks to staff and support their deliverables.
• Participate in process improvement initiatives and promote innovative study execution approaches.
• Support unmasked tasks as assigned, such as managing unmasked files or data review.

Qualifications

You are:

• Hold an undergraduate degree or equivalent in a relevant field; licensed healthcare professional (e.g., registered nurse) preferred.
• Have at least 8 years of relevant study management experience.
• Demonstrate strong interpersonal and leadership skills.
• Capable of understanding and implementing strategic directions for clinical studies.
• Use data-driven approaches for planning, execution, and problem-solving.
• Possess effective communication skills, including verbal, written, and presentation abilities.
• Proactive, disciplined, and able to meet deadlines with good time management.
• Skilled in influencing and negotiating.
• Experienced in budget management.
• Aware of industry trends.
• Able to build productive teams and collaborations.
• Experienced in vendor management.
• Proficient in trial management systems and MS Office applications, including Project, PowerPoint, Word, Excel, IVRS/IWRS, and EDC.
• Experienced in global clinical trial operations, including protocol development.
• Knowledgeable of ICH/GCP and regulatory guidelines.
• Possess excellent project management and organizational skills.
• Willing to travel up to 25% as needed.

What ICON Can Offer You

Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Along with a competitive salary, we offer various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Flexible benefits such as childcare vouchers, gym memberships, and travel discounts

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment. If you require accommodations during the application process, please let us know.

If you're interested but unsure if you meet all requirements, we encourage you to apply—your skills might be exactly what we need.