Local Study Associate Director – FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Directs Local Study Team(s) (LSTs) at the country level to execute designated components of clinical studies in accordance with established resources, budget, and timelines.

• Ensures identification of sites, completion of site qualifications, set up, initiation, monitoring, closure, and documentation archiving.

• Manages the site selection process by pinpointing potential sites/investigators, conducting initial Site Quality Risk Assessments, and performing Site Qualification Visits.

• Supervises, administers, and coordinates monitoring activities from site activation through to the conclusion of the study.

• Proactively identifies risks and facilitates the resolution of intricate study challenges and issues.

• Assists SMM in various initiatives (local, regional, or global) as agreed upon with the SMM Line Management.

⛳️ Requirements

• Over 3 years of experience in Development Operations (CRA, SrCRA) or other relevant fields.

• Strong understanding of international guidelines, including ICH GCP, as well as applicable local regulations.

• Demonstrated ability to lead and inspire cross-functional teams to successfully deliver clinical trials on or ahead of schedule, within budget, and with the required quality.

• A Bachelor's degree in a related field, ideally in life sciences, or an equivalent qualification that supports the skills and capabilities necessary for the role and ensures effective execution of responsibilities while maintaining appropriate interactions with internal and/or external clients.

• Proficiency in English and local languages is essential.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development opportunities

• Health insurance

• 401(k) matching