Job Description
PURPOSE OF JOB:
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.
MAJOR DUTIES AND RESPONSIBILITIES:
Responsible for performing or providing Clinical Operations oversight of in-house and outsourced activities in the following areas:
- Supports/Leads the set-up and on-time execution of clinical study tasks, while ensuring the trial is conducted to RAPT 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 infra-structure systems (EDC, IRT, CTMS, eCOA, etc.)
- As needed, works closely with RAPT Biomarker Team staff and external personnel (Central Labs, specialty labs, clinical trial study sites, etc.) 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
To accomplish the above, the Clinical Trial Manager will be required to:
- Develop and maintain strong internal and external relationships with key stakeholders
- Lead the team when making decisions/recommendations that require cross-functional input and that have cross-functional implications
- Effectively communicate with key stakeholders at all levels of the organization
- Quickly and accurately identify issues and propose and implement effective solutions
- Prospectively identify risks and mitigation approaches, and implement them as appropriate
EDUCATION REQUIREMENTS:
- Bachelor's 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
EXPERIENCE 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.
OTHER QUALIFICATIONS:
- Ability to work on-site at our South San Francisco office 3 days per week
California law requires pay information in job postings. The specific rate will depend on the successful candidate's qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $157,400 (entry-level qualifications) to $165,000 (highly experienced).
Job Tags
Full time, Work at office, 3 days per week,