Senior Clinical Data 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 DATA MANAGER
We are seeking a highly motivated individual to join TP Therapeutics as a Senior Clinical Data Manager, reporting into the Senior Director, Biostatistics. The Clinical Data Manager (CDM) will work independently and be accountable to priorities and ensure all data management procedures are executed with high attention to detail, accuracy and timeliness. Additionally, the CDM will work on multi-functional teams and will maintain program/project level perspective, focus and communicate effectively on data management issues, activities, and deliverables.
- The CDM will use data review best practices and associated data review tools to identify trends and any safety signals.
- Provide functional management of studies and or compounds being reviewed.
- Perform and coordinate the data review deliverables across studies and at the program level.
- Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
- Provide data review subject matter expertise support for studies, as needed, within Clinical Sciences group.
- Review and approve CRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements. Assist in developing data management process and procedure improvements
- Perform user acceptance testing on database applications and data transfers
Create required study documentation (i.e. DMP, DVS and CRF Completion Guidelines)
- Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Generate and review reports and listings to maintain data integrity and reporting
Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers
- Act as clinical data management liaison/lead to communicate study status, timeline updates, scope change with internal project management and departmental leadership
- Manage and/or liaise with 3rd party vendors specifically related to data collection, review and analysis, and communicate project timelines
- Perform external data reconciliation; assist in developing/designing reports and computer programs to assist in the data review process and provide operational metrics
- Develop strong working relationships and maintain effective communication with Clinical Operations, Safety Regulatory, Biostatistics, Programming, and Quality Assurance
- At least 7 years of clinical experience in pharmaceutical industry.
- Extensive understanding of the processes associated with reviewing and delivering quality data.
- Strong field monitoring experience an asset
- Extensive Clinical Research experience, ideally on the side of the sponsor and with a track record of successful regulatory submissions
- Strong background in Oncology
- Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.
- Familiar with database systems; technically competent with Microsoft Excel and ideally, Access.
- Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.
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.