Apply on Employer Site

RAPT Therapeutics · 1 day ago

Clinical Trial Manager

South San Francisco, CA

Full-time

Hybrid

Entry, Mid Level

$157K/yr - $165K/yr

2+ years exp

RAPT Therapeutics is a company focused on clinical research, and they are seeking a Clinical Trial Manager to oversee day-to-day clinical operations for their trials. The role involves collaborating with various teams to ensure high-quality data delivery while adhering to regulatory standards and managing vendor relationships.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics

Responsibilities

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

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

Qualification

Clinical OperationsClinical Trial ManagementVendor ManagementRegulatory ComplianceImmunology ExperienceDermatology ExperienceCross-functional CollaborationRisk ManagementStakeholder ManagementCommunication SkillsProblem SolvingTeam Leadership