Manager, Clinical Trial Management
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
The Clinical Trial Manager (CTM) of Clinical Trial Management will be responsible for coordination and implementation of clinical operations activities of multiple clinical trials. In addition, he or she will be responsible for properly resourcing, managing and executing clinical studies within budget and in accordance with established timelines and quality standards.
Responsibilities include, but are not limited to:
- Study Planning and Management. Coordinate and actively participate in the development of studyrelated documents (investigator brochure, clinical protocols, informed consent forms, case report forms, clinical study reports, amendments, adverse event reporting, site training manuals, and patient recruitment plans) and analysis plans (including data collection and management); Monitor study progress and maintain timeline from initiation through publication of study results; work very closely with the clinical lead to advance the studies.
- Quality Assurance. Responsible for development, implementation and compliance of Standard Operating Procedures; Develop quality control processes and monitoring plans to ensure that all clinical activities are compliant with Good Clinical Practices and regulatory guidelines; Participate in the conduct of audits and support regulatory inspections related to GCP.
- Clinical Trial Budgeting. Work with finance department on the development and negotiation of trial site budget and clinical trial agreements; Forecast and manage clinical trial budgets and FTE costs; Ensure accurate accruing of study costs; Review vendor invoices against contract and work completed; Oversee reconciliation of site payments against patient visits to ensure accurate payments; Identify and communicate variances.
- Trial Site Management. Maintain strong relationships with research sites, and trial site administrators; Lead effective communications with trial sites for specimen tracking, study conduct and timely data review to identify trends and discrepancies; Contribute to development of abstracts, presentations and manuscripts for studies.
- Vendor Management. Responsible for collection and preparation of all information needed to facilitate selection, onboarding and management of CRO and clinical vendors for outsourced activities; Develop statements of work, budgets and timelines; Responsible for gap analysis, performance management, risk management and issue resolution.
- Supply Chain Management. Coordinate and plan for availability of clinical and nonclinical supplies required for trial execution.
- Other duties as assigned.
- At least 5 years of experience in clinical operations within the biopharma industry
- Demonstrated ability to successfully develop, implement, manage and complete oncology clinical trials on time and on budget
- Expert working knowledge of study initiation, execution, analysis and closing procedures
- Intimate knowledge of GCP and strong working knowledge in FDA regulations, ICH guidelines and the application to the conduct of clinical trials.
- Experience in cell therapy or stem cell transplant clinical trials preferred
- Prior experience working in a start-up environment or small company is a plus
- Experience with investigatorinitiated and industry-sponsored studies
- Significant experience in all aspects of site initiation and management, clinical trial budget and operational planning, site monitoring and risk assessment, corrective action plans, query generation and management, data review and cleaning, QA of the operations, SOP writing and risk mitigation and enrollment acceleration and compliance.
- Experience in working with clinical trial teams, including data management, clinical sciences, medical monitors, regulatory and QA
- Aspires to work in a matrix environment within the clinical team
- Excellent leadership, organizational and multitasking skills in a fast-paced start-up environment
- Very dynamic and energetic, hands on approach to the challenges
- Excellent written and verbal skills and strong interpersonal skills required
- Deep understanding of clinical trial design, protocol development and review, running the clinical trial meetings
All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.
No phone calls please and no agencies or recruiters.