Study Start-Up Lead, Dermatology Trials (Poland)

TFS HealthScience; Polska; Vor Ort; PLN 180.000 - 250.000; Vollzeit

Zusammenfassung

TFS HealthScience in Poland is seeking a Study Start Up Lead to drive start-up activities from award to site activation within our CDS Dermatology team. You will coordinate EC/IRB submissions, ethics approvals, and regulatory requirements to ensure timely project delivery.

Join a global mid-size CRO that values collaboration, quality, and patients' lives, offering professional growth and a supportive, fast-paced environment.

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• Minimum 4 years of clinical research experience with focus on study start-up.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.

Aufgaben

• Lead and oversee study start-up activities across assigned projects from award to site activation.
• Develop and maintain start-up plans, timelines, and project milestones.
• Partner with Project Managers to identify risks and implement mitigation strategies.
• Coordinate Ethics Committee (EC/IRB) submissions and collaborate with Regulatory teams on Health Authority requirements.
• Support site feasibility, site activation, and greenlight processes.
• Coordinate clinical trial agreement negotiations alongside Legal and operational teams.
• Ensure study documentation is complete, accurate, and submitted to the Trial Master File.
• Monitor start-up metrics and provide regular progress updates to project stakeholders.
• Support continuous improvement initiatives, SOP development, and operational best practices.
• Contribute to bid defenses, proposals, and business development activities when required.

Kenntnisse

Clinical research

Study start-up coordination

Regulatory knowledge

English communication

Project coordination

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

TFS HealthScience in Poland is seeking a Study Start Up Lead to drive start-up activities from award to site activation within our CDS Dermatology team. You will coordinate EC/IRB submissions, ethics approvals, and regulatory requirements to ensure timely project delivery.

Join a global mid-size CRO that values collaboration, quality, and patients' lives, offering professional growth and a supportive, fast-paced environment.