Global Clinical Trial Coordinator

Gan & Lee Pharmaceuticals; Denmark; Presencial; DKK 583.000 - 777.000; Jornada completa

Descripción de la vacante

Gan & Lee Pharmaceuticals seeks a Clinical Operations Professional to work closely with the Clinical Operations Team on day-to-day management of clinical studies. The role will be based in Denmark or the United States, reporting to the Head of Clinical Operations.

You will help ensure quality and regulatory compliance, maintain study materials, and support study teams across global studies with administrative and coordination duties.

Formación

• College degree in relevant field or equivalent years of direct industry related experience.
• Minimum 5 years of industry or equivalent experience.
• Working with global clinical studies in different study phases.
• Must have good communication skills (oral and written).
• Ability to work in a cross-functional team.
• Willingness to adapt to changing priorities and assignments.
• Familiarity with Microsoft Word, Excel, Project, and PowerPoint.
• Efficient, organized, and capable of multitasking.
• Working knowledge of GCP standards, ICH, and Federal Regulations.
• Process oriented with strong attention to detail.
• Self-motivator and team player in a fast-paced environment.

Responsabilidades

• Attend GCP training as designated and appropriate for the role to ensure quality and compliance.
• Adhere to company policies and procedures with integrity.
• Participate in planning, organization, and follow-up of meetings.
• Review meeting materials for accuracy and clarity; prepare/update slides.
• Provide administrative support to Study Team as needed.
• Participate in study team meetings and maintain internal and external contact lists.
• Collaborate with CROs to compile Investigator Initiation Packets and Regulatory Documents.
• Create and maintain study activity trackers and logs (e.g., Start-up, Monitoring, Enrollment).
• Review vendor/Investigator site documents for legibility and conformity to SOPs and protocol.
• Assist in start-up activities and development of informed consent and related documents.
• Create and file TMF materials and archive study documents.
• Track confidentiality, consulting, and study agreements.
• Assist in processing and tracking invoices and financial records.
• Perform monthly financial reconciliation; may serve as Data Retention Coordinator.

Conocimientos

Communication

Cross-functional teamwork

Adaptability

MS Office proficiency

Multitasking

GCP/ICH/Regulatory knowledge

Detail oriented

Self-motivated

Team player

Educación

College degree or equivalent experience

Herramientas

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft PowerPoint

Descripción del empleo

Gan & Lee Pharmaceuticals seeks a Clinical Operations Professional to work closely with the Clinical Operations Team on day-to-day management of clinical studies. The role will be based in Denmark or the United States, reporting to the Head of Clinical Operations.

You will help ensure quality and regulatory compliance, maintain study materials, and support study teams across global studies with administrative and coordination duties.