Clinical Trial Manager/Senior Clinical Trial Manager

Position Summary:

• Serves as the clinical trial lead responsible for planning, conduct, and oversight of operational portions of clinical studies.
• Ensures studies are conducted per protocol, SOPs, ICH-GCP, and applicable regulatory requirements.
• Acts as primary clinical point of contact with clients and collaborates on budget management.

Essential Functions:

• Develops study-related clinical documents and training materials for CRAs and vendors.
• Generates site lists, drives feasibility, identifies enrollment risks, and develops recruitment/retention strategies.
• Leads internal clinical team meetings, manages eTMF, and supports investigator meetings.

Qualifications:

• Requires bachelor's degree in science or health-related field and minimum 7 years of clinical research experience.
• Preferred advanced degree and proven experience in pharmaceutical or device research.
• Strong skills in Microsoft Office, communication, organization, and knowledge of ICH-GCP and regulatory guidance.