Clinical Trial Operations Specialist
1 week ago
Clinical Trial Liaison Manager at BESTMSLs
Overview
This Hybrid office-based position involves regular travel in the field, overseeing site trial delivery, subject recruitment, protocol adherence, and data quality. Based in North America, you will represent the company in site relations, support study teams with startup and recruitment, and manage in-field activities of the contracted CRO, focusing on the CRA team.
Main Responsibilities
- Site and Investigator Relationship Management:
Act as an ambassador for the company, supporting its positioning as a sponsor of choice, and representing the sponsor with investigators and site staff.
Drive enrollment at the principal investigator (PI) level, collaborating closely with clinical research associates (CRAs) and study coordinators. - Patient Recruitment and Enrollment:
Oversee and track patient recruitment for sites, proactively identifying ways to prevent delays.
Support the development of recruitment and retention plans in collaboration with Lead CSM, CSM vendor/CRO, or Local CSM. - Monitoring and Compliance:
Ensure data quality and integrity meet Good Clinical Practice (GCP) standards and local regulations through data reviews (remote and onsite).
Oversee the activities of local CRO teams to ensure effective sponsor oversight of monitoring activities.
Qualifications
Bachelor's degree required, preferably in the life/physical sciences. Strong scientific background with at least five years of clinical development experience. Extensive clinical development and pharmaceutical experience with a good knowledge of the applicable regulations in order to have a thorough understanding of the processes associated with executing clinical development plans. Experience working on audits, regulatory inspections, and CAPAs. Experience working on Phase 1-4 clinical development studies. Highly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases.
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