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IDEAYA Biosciences · 1 day ago

Senior Clinical Trial Manager

South San Francisco, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$166K/yr - $205K/yr

8+ years exp

IDEAYA Biosciences is a precision medicine oncology company focused on developing transformative therapies for cancer. The Senior Clinical Trial Manager will lead the Study Execution Team and oversee clinical trials, ensuring they are completed on time and within budget while adhering to regulations and guidelines.

BiotechnologyHealth CareOncologyTherapeutics

Responsibilities

Lead/support SET to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision

In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit

Manage CRO and/or other clinical vendors to ensure that project and Corporate goals are achieved on time and within budget

Lead development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)

Fiscal and contracts management: oversee and manage overall study budget and contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates

Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT

Clinical data review of data listings and summary tables, including query generation

Oversee site management (e.g., review of monitoring reports, quality metrics) in collaboration with CRO

Lead other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)

Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines

Demonstrate command of study status and proactively communicate issues or changes that may impact quality, timelines and costs to Clin Ops management and key stakeholders

Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation

Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials

Partner with cross functional stakeholders to identify and remove executional barriers in order to ensure timelines and goals are met

Collaboratively drive cross functional decision-making while ensuring clarity and timely communication once consensus is reached

Aggressively manage issues that have been escalated by other Clin Ops team members, cross functional stakeholders, vendors, CROs and other study partners to efficient closure

Train investigators and site staff, vendors and team members on study protocol and trial conduct processes

Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed

Qualification

Clinical trial managementOncology experienceFDA regulations knowledgeICH/GCP guidelines knowledgeVendor managementBudget managementCross-functional collaborationAnalytical skillsCommunication skillsProblem-solving skillsDetail-orientedTeam player

Required

Bachelors in life sciences or related discipline with 8-10 years of experience in clinical and drug development

Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines

Self-motivated and strive for continuous improvement and embrace innovative ideas in daily work

Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships

Detailed oriented and creative thinker with a passion for process optimization

Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company

Analyze and triage problems, prioritize accordingly, and propose solutions

Ability to travel as required (up to 40%)