Clinical Trial Manager

Role Summary

The Clinical Trial Manager will provide day-to-day clinical operations oversight and support for RAPT clinical trials as assigned. This cross-functional role involves working directly with the study team, as well as external functional area/support staff and vendors, to ensure execution on the clinical strategy and delivery of high-quality clinical trial data on time and within budget. Works under minimum supervision and contributes technical and operational expertise to achieve RAPT’s Clinical Development goals.

Responsibilities

• Supports/Leads the set-up and on-time execution of clinical study tasks, while ensuring the trial is conducted to quality standards and in compliance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
• Collaborates with cross-functional teams to ensure effective delivery of the assigned activities to meet project milestones
• Supports/Leads identification, selection, contracting and management of study vendors/CROs and development of vendor scope of work (SOW)
• Supports/Leads the development and review of clinical study plans (Clinical Monitoring Plans, Data Management Plans, Safety Management Plans, Communication Plans, etc.), and other project/study-related documents including training materials, forms, logs, presentations, etc.
• Acts as primary point of contact for assigned trial(s) for vendors, partners, investigational sites, and RAPT internal teams
• Participates in specification development, design, set-up and UAT of trial infrastructure systems (EDC, IRT, CTMS, eCOA, etc.)
• As needed, works closely with RAPT Biomarker Team staff and external personnel on clinical laboratory activities including specimen management & logistics, data management, and issue identification and resolution
• Collaborates with RAPT Clinical Drug Supply Manager and internal and external CMC / Supply Chain personnel to forecast investigational product needs and identify distribution, storage, and accountability requirements
• Collaborates with RAPT Clinical Project Manager and Finance personnel to ensure accuracy and financial information related to clinical trial progress, including enrollment information, timeline status, and budget forecasts and updates
• Writes/Contributes to clinical trial protocols and protocol-associated documents including Informed Consent Forms and other documents as needed or requested
• Coordinates/Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the vendor and RAPT internal team, as needed
• Manages clinical monitoring activities, overall site performance, and ensures compliance with Good Clinical Practices (GCP) and applicable regulations
• Reviews monitoring trip reports, ensures follow-up of action items to resolution and escalates critical issues and risks, as necessary
• Responsible for ongoing review/oversight of TMF and other records as assigned
• Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings as required
• Other duties as assigned

Qualifications

• Bachelor‚Äôs degree required, preferably in a scientific discipline. Advanced degree preferred. May consider a combination of experience and education in lieu of strict adherence to educational requirements
• Minimum of 2 years of clinical operations experience
• Recent experience managing ex-US sites on a Global Clinical Trial is desired
• The ideal candidate will have recent experience managing clinical trial(s) in immunology and/or dermatology
• Experience directly managing clinical vendors, including CRO, eCOA, etc.
• Ability to work on-site at our South San Francisco office 3 days per week

Skills

• Strong cross-functional collaboration and stakeholder management
• Effective communication with stakeholders at all levels
• Problem identification and solution development with proactive risk mitigation
• Experience with clinical trial documentation and systems (EDC, IRT, CTMS, eCOA)

Education

• Bachelor‚Äôs degree required; advanced degree preferred

Additional Requirements

• On-site work required at the South San Francisco office 3 days per week