Senior Clinical Trial Associate

Gan & Lee Pharmaceuticals; Denmark; On-site; DKK 583,000 - 777,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Communication

Cross-functional teamwork

Adaptability

MS Office proficiency

Multitasking

GCP/ICH/Regulatory knowledge

Detail oriented

Self-motivated

Team player

Education

College degree or equivalent experience

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft PowerPoint

Job description

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.