Senior Clinical Trial Manager
TP Therapeutics, Inc. (TP) is a clinical-stage structure-based oncology drug design company founded in October 2013 by Dr. J. Jean Cui, the lead inventor of Pfizer’s oncology drug crizotinib and lorlatinib. The TP team is focused on the design and development of novel chemical entities within oncology for established oncogene drivers with high incidence of secondary resistance mutations; newly identified disease-driven targets; and potential targets regulating the tumor microenvironment and tumor immunity. For more information, please visit us at www.tptherapeutics.com.
Senior Clinical Trial Manager
We are seeking a highly motivated individual to join TP Therapeutics as a Senior Clinical Trial Manager (CTM), Clinical Operations reporting into the VP of Clinical Operations. The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. The CTM ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The scope of this position requires excellent organizational, communication, and leadership skills, with strong experience in executing all phases of clinical trials
- Drives all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.
- Drive and oversees project timelines, CRO and vendor performance to meet departmental and corporate goals.
- Ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
- CRO Selection: Solicit and review proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.
- CRO/Vendor Management: Communication/oversight of Vendors/CROs, primary point of contact for questions; follow up on issues or outstanding items. Resolve issues and escalate to management as needed.
- CRO Oversight: Efficiently 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.
- Site selection/Visit report review: Review Qualification Visits as a priority and inform CRO whether site is approved for selection. Review Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.
- Contract/Budget Oversight and Management: CTM will track spending of clinical trials against company budget. Review and approve invoices from vendors/consultants as per contract. Obtain executive team management approval of changes to contracts/budgets.
- Manage the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
- Medical Writing: Contribute to and/or author protocols, protocol amendments, clinical study reports, initial IND and annual IND updates, Investigators Brochure and updates, ICF etc.
- Data Monitoring Committee (DMC): Work with CRO/Vendor to select DMC members, develop the DMC Charter, obtain internal review of DMC documents and plan DMC meetings.
- Monitor study progress: Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRO CRAs as applicable.
- Plan and present at Investigator Meetings and/or Site and CRA trainings.
- Participates in study strategic development, Line Listing Review and Clinical Study Report preparation, as appropriate.
- Coordinate the oversight of sample collection, process and analysis (i.e., tissue samples, lab samples, scans, PK samples).
- Track and coordinate trial related materials, including study drug and other clinical trial supplies.
- Clinicaltrials.gov: Act as administrator for the Protocol Registration System (PRS) & get internal agreements for entries, register studies & submit results on PRS. Responsible for keeping information updated for ongoing clinical trials.
- Participate in risk management discussions with the cross-functional study team and contribute to maintenance of a comprehensive risk management plan throughout the study lifecycle
- Perform periodic reviews and QC of the 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.
- Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.
- Travel as required to carry out responsibilities.
- Organize and manage internal team meetings and other trial-specific meetings.
- Participate in the development, review and implementation of departmental SOPs and processes.
- Bachelors in a scientific or health care field is required
- Minimum of 5-7 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 for 3+ years
- Clinical operations experience at a small or mid-size company
- Experience in running a trial from start to finish; protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out
- Developed leadership skills to manage a clinical study team
- Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities
- Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.
- A strong communicator with excellent verbal and written communication skills
- A highly collaborative person who is able to respond to changing circumstances and need
- Ability to travel up to approximately 20-25%
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.