Senior Manager, Data Management
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Turning Point Therapeutics is hiring a Senior Manager of Data Management in San Diego. The Senior Manager, Data Management will assist in the coordination of data management activities from study start-up, data processing, and database close-out projects sponsored by Turning Point Therapeutics
Duties & Responsibilities:
- Provide Clinical data management support to Clinical Operations team and Biostatistics team.
- Participate in the development of Data Management SOPs and Work instructions.
- CRO oversight for all DM activities at the program and/or study level.
- Mentor and assist CDM’s and Sr. CDM’s in programs
- Participates in the review of Clinical research documents (eg. Protocols, CSRs, SAPs).
- Oversee the development of study-specific Data Management Plans (DMPs), ensure DMP is maintained throughout the lifecycle of the study project and ensures DMP is followed according to study design and requirements.
- Participate in the design of CRFs as part of Turning Point’s standard library.
- Oversee the development of a study-specific database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
- Oversee the development of Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from the vendor.
- Oversee User Acceptance Testing (UAT) and maintain findings logs
- Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Ensure clinical data within EDC is in quality to lock and freeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- Assist in defining and/or create data listings, summary table validation, data specifications, and/or process data transfers in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for the closing of study trial in EDC or other clinical data management DBs.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
- Assist and provide input into the study and project-level data analysis plan.
- Coordinate and communicate with DB vendors on a consistent basis to address Clinical teams’ requests, project plans, and/or eCRF development activities.
- Collaborate with IT and implementation team(s) to address Clinical application requests
- Participates in the preparation and presentation of data, when applicable.
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
- Participate in conference calls and/or meetings with vendors.
Education / Experience:
- BS or MS in nursing, biological sciences or other medically related field
- At least 10 years of relevant pharmaceutical, biotech, or CRO experience in clinical data management, of which some is to include experience in clinical trial database design and data programming.
- Oncology study experience preferred.
- eCTD submission prep experience.
- Implementation of CDISC SDTM and CDASH standards.
- Excellent organizational project management skills with great attention to detail and the ability to multitask.
- Excellent verbal and written communication skills, as well as oral presentation abilities required.
- Excellent interpersonal skills.
- Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Clinical Research, CMC, Pre-Clinical, BioStats).
EEO & Employment Eligibility
Turning Point 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. Turning Point 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. Turning Point Therapeutics is an E-Verify employer.