Manager I, Clinical Trials

Role Summary

The Manager I, Clinical Trials leads key study activities across start-up, execution, and close-out, coordinating study plans, vendors, drug inventory, lab supplies, site management, and enrollment. They review study documents, support site qualification, train staff on GCP-compliant procedures, and provide oversight of monitoring when delegated to CROs. The role includes preparing project tools and reports, and may serve as a resource for clinical trials management. Occasional travel may be required. The position reports to the Associate Director, Clinical Operations, and will be based in Irvine with a hybrid/remote option.

Responsibilities

• Oversees and manages key study activities including study start-up, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, and screening and enrollment activity.
• Reviews protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms, and other study-related documents; participates in user acceptance testing for eCRFs and recommends operational changes as required.
• Develops key study documents: training materials, site study materials, and related study documentation.
• Assists in the identification, selection, and site qualification processes of study sites.
• Ensures study staff have proper materials and instructions to safely enter patients into the study; trains staff in conducting the study per GCP and per protocol.
• Arranges and oversees site visits.
• When monitoring is delegated to a CRO, provides Sponsor oversight of monitoring activities.
• Organizes and presents at site initiation visits and/or Investigator Meetings.
• Manages and tracks drug supply inventory and updates supply tracking with projection vs usage.
• Reviews study budgets and tracks, processes, and manages vendor invoices to support study financial tracking.
• Assists in creating project/tools to report and oversee study-specific metrics as needed.
• Reviews and assists in the preparation of Clinical Study Reports (CSRs).
• May serve as a resource for others within the company for clinical trials management expertise.

Qualifications

• Bachelor’s degree (life science preferred) and five years clinical experience or Associate’s degree and 7 years clinical experience.
• Minimum of 2 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company.
• Experience managing outside vendors (e.g., CROs and labs).
• Thorough knowledge of ICH/GCP R2 Guidelines and working knowledge of health authority requirements and regulations.
• Demonstrated ability to attain and maintain a working knowledge of applicable Standard Operating Procedures at Tarsus and with CRO/vendors.
• Ability to work independently as well as collaboratively in an efficient manner.
• Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner.
• Flexibility to adjust to changing needs in the Clinical Department and organization.
• Excellent knowledge of MS Office, Excel, and PowerPoint
• Strict attention to detail.

Skills

• Clinical trials management
• Vendor management
• GCP compliance
• Documentation and reporting

Education

• Bachelor’s degree (life sciences preferred) or Associate’s degree with extended clinical experience as outlined above.

Additional Requirements

• Travel up to 20% may be required.