Global Senior Clinical Trial Associate

Gan & Lee Pharmaceuticals; New York (NY); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Gan & Lee Pharmaceuticals USA Corporation seeks a Clinical Operations professional to support day-to-day management of clinical studies under the Head of Clinical Operations. The role will be based in either Denmark or the US, collaborating with the Clinical Operations Team to ensure quality and regulatory compliance.

The position requires a college degree or equivalent experience, 5+ years in global clinical studies, and strong skills in GCP/ICH, MS Office, and cross-functional collaboration.

Formación

• College degree in relevant field or equivalent years of direct industry related experience.
• At least 5 years of industry experience, with global clinical studies across phases.
• Strong communication, cross-functional collaboration, and adaptability.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

Responsabilidades

• Ensure quality and compliance in all actions by attending GCP training as designated and appropriate for role.
• Adhere to company policies and procedures.
• Exercise the highest level of integrity at all times.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time.
• Participate in the planning, organization, and follow-up of meetings as needed.
• Review meeting materials for accuracy, completeness, clarity, legibility, and typos.
• Prepare and/or update slides.
• Provide administrative support, as needed, to Study Team.
• Participate in study team meetings; produce and track internal meeting agenda, minutes, and action items when necessary.
• Maintain study contact lists, updating internal and external vendor contact information, as needed.
• Compile, distribute, collect and review Investigator Initiation Packets and Regulatory Documents for site initiation/investigational product release with CROs
• Create and maintain internal study activity trackers and study logs (e.g., Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs).
• Review vendor/Investigator site documents/plans for legibility and conformity to SOPs and protocol.
• Assist with start-up activities (e.g., informed consent documents).
• Create, file, track, QC, and archive the TMF and electronic study files.
• Track processing of Confidentiality, Consulting, and Study Agreements.
• Assist in processing and tracking invoices; ensure timely processing.
• Assist in maintenance of financial records/invoice tracker.
• Assist in monthly financial reconciliation against contracts.
• May serve as Data Retention Coordinator.
• Perform other duties as required.

Conocimientos

Excellent communication skills

Cross-functional teamwork

Adaptable to changing priorities

MS Office proficiency

Multitasking and organizational skills

GCP/ICH/Federal Regulations knowledge

Process-oriented with attention to det

Self-motivated and proactive

Team player in fast-paced environment

Educación

College degree in relevant field or equivalent

Descripción del empleo

Gan & Lee Pharmaceuticals USA Corporation seeks a Clinical Operations professional to support day-to-day management of clinical studies under the Head of Clinical Operations. The role will be based in either Denmark or the US, collaborating with the Clinical Operations Team to ensure quality and regulatory compliance.

The position requires a college degree or equivalent experience, 5+ years in global clinical studies, and strong skills in GCP/ICH, MS Office, and cross-functional collaboration.