Senior Global Clinical Trials Associate (Phase 2–3)

Liquidia Technologies; United States; Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Liquidia Technologies is seeking a Sr. Clinical Trial Associate to join the Clinical Operations team. The role focuses on executing and managing studies within the company’s clinical development plans, coordinating with internal and external team members.

The candidate will have 4+ years of clinical trials experience, a solid understanding of ICH GCP, and exposure to Pulmonary Hypertension or inhalation research is preferred. Travel up to 15% may be required.

Qualifikationen

• Bachelor’s degree in a related discipline and a minimum of 4 years of clinical trials or Sponsor experience.
• Experience in Phase 2–3 clinical trials, including global studies.
• Strong knowledge of ICH GCP regulations.
• Prior exposure to Pulmonary Hypertension or inhalation research preferred.
• Excellent written and verbal communication; ability to multitask in a fast-paced environment.
• Willingness to travel up to 15%.

Aufgaben

• Assist with project start-up, including budgets, contracts, and grant payments.
• Collaborate with Program Leaders to develop study-related materials.
• Oversee and manage clinical project documents (Regulatory, CRF, Monitoring Reports).
• Review CROs and vendors’ work and provide feedback to the study manager.
• Maintain communications with study personnel and investigators; build relationships.
• Route and file communications, logs, and protocol deviation assessments.
• Copy, distribute, and file Serious Adverse Event communications.
• Prepare and distribute project status reports and study memorandums.
• Support electronic and paper document-tracking systems for studies.
• Review grant calculations and forward invoices and site payment letters.
• Review Investigator and Project files; follow up on discrepancies.
• Assist in SOPs and work instruction maintenance and Investigator Meeting prep.
• Update CTMS and clinicaltrials.gov; maintain Trial Master File and study trackers.
• Support UAT for clinical systems including EDC and IRT.

Kenntnisse

Clinical trials

ICH GCP knowledge

Pulmonary hypertension

Communication skills

Time management

Multitasking

Travel willingness

Ausbildung

Bachelor's degree

Jobbeschreibung

Liquidia Technologies is seeking a Sr. Clinical Trial Associate to join the Clinical Operations team. The role focuses on executing and managing studies within the company’s clinical development plans, coordinating with internal and external team members.

The candidate will have 4+ years of clinical trials experience, a solid understanding of ICH GCP, and exposure to Pulmonary Hypertension or inhalation research is preferred. Travel up to 15% may be required.