We are seeking a highly motivated individual to join Turning Point Therapeutics as a Clinical Trial Manager. The Clinical Trial Manager will be responsible for the day-to-day management of a diverse program of clinical trials, including management of contract CROs conducting company sponsored clinical trials.
- Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
- Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
- Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
- Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.
- Coordinate/plan investigator meetings and/or site and CRA training.
- Perform financial management, including review and approval of site and vendor invoices.
- Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
- Perform review and QC central clinical files and trial master file.
- Identify potential study issues and recommend and implement solutions or corrective actions as needed.
- Serve as a liaison and resource for investigational sites; review investigator contracts and site payments.
- Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
- Organize and manage internal team meetings and other trial-specific meetings.
- Participating in the development, review and implementation of departmental SOPs and processes.
- Bachelors or Masters degree or equivalent in a scientific or health care field is required.
- Minimum of 3-5 years of clinical trial management experience, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
- Experience in managing oncology clinical trials and/or orphan disease indications preferred.
- Someone with biotech or pharmaceutical experience as an in-house CTM.
- Clinical operations experience at a small or mid-size company.
- Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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