Summary

This position reports to the Head of Clinical Operations, Gan & Lee Pharmaceuticals USA Corporation or designee. This role is responsible for working side-by-side with the Clinical Operations Team, assisting with day-to-day management of clinical studies. The position will be based in either Denmark or US.

Education and Credentials

• College degree in relevant field or equivalent years of direct industry related experience.

Experience

• At least 5 years of industry or equivalent experience.

• Working with global clinical studies in different study phases.

Skills

• Must have good communication skills (both oral and written).

• Ability to work in cross-functional team.

• Willingness to adapt to changing priorities and assignments.

• Familiarity with Microsoft Suite of applications including Word, Excel, Project, and PowerPoint.

• Efficient, organized, and capable of multitasking.

• Working knowledge of GCP standards, ICH, and Federal Regulations.

• Process oriented with a strong attention to detail.

• Self-motivator.

• Team player who thrives in fast-paced environment.

Responsibilities

Under supervision and in accordance with all applicable federal, state and local laws/regulations (including local/regional regulations outside US, as required), GCP/ICH guideline, and the Company’s policies, procedures, and guidelines, this position is responsible for the following:

• 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 (planned and/or on an ad hoc basis); 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 (for some studies), and review for completeness, Investigator Initiation Packets and Regulatory Documents required for site initiation/investigational product release in collaboration with CROs 

• For some studies, create and maintain internal study activity trackers and study logs, (i.e., Study Site Start-up, Regulatory Documents, Monitoring Visit Trip Reports, Enrollment Logs, etc.).

• Review vendor/Investigator site documents/plans (e.g., monitoring plan) for legibility, typographical errors, and conformity to available source documentation (i.e., applicable SOPs, study protocol, etc.).

• For some studies, assist with start-up activities (i.e., development of informed consent and other study related documents).

• Create, file, track, QC, and archive the TMF, including filing and maintenance of electronic study files, as needed, as well as general study materials.

• Track the processing of Confidentiality, Consulting, and Study Agreements.

• Assist in processing and tracking investigator/vendor invoices; ensure invoices are processed in a timely manner.

• Assist in the maintenance of financial records/invoice tracker.

• Assist in performing monthly financial reconciliation against vendor/external partner contracts.

• May serve as Data Retention Coordinator in alignment with company policy.

• Perform other duties as required.