Senior Data Manager
Pionyr Immunotherapeutics Inc., a growing South San Francisco Bay based, clinical stage immuno-oncology company focused on novel approaches to generate anti-tumor immunity, is seeking an organized, motivated, and detailed Senior Data Manager, in our Biometrics department who will be reporting to the Director of Clinical Data Management.
The Senior Data Manager (SDM) will be responsible in managing outsource clinical studies to partner contract research organization (CROs) and enabling the execution of the data management life cycle process (e.g., CRF design through Database Lock & Archival). The SDM will ensure and coordinate with clinical operations, statistics, programming, pre-clinical sciences, and early development team(s) to ensure the accurate and complete data collection for our clinical oncology studies. The candidate will be the key contact for Data Management related issues or problems and will liaise with internal or external customers to ensure, manage, resolve, and escalate issues, when necessary, through resolution of key problems ensuring that data management deliverables are maintained.
Specific Responsibilities include but not limited to:
- Reviews and understands study protocols, (along with amendments) and other clinical related materials.
- Must critically follow-through (via phone, not rely solely on email or text messaging) and engage outside vendors or internal customers to complete tasks and get the job done.
- Use of critical thinking, when a vendor or CRO advises of a completed task, and yet during the review of that task is not completed and advise the vendor for corrective action.
- Provides leadership and coordinates the activities of data management staff at the CROs ultimately resulting in database lock and release of data for analyses.
- Ability to create if need be quality assurance procedures for ongoing/final data review and quality assurance processes.
- Actively participates in clinical sub-teams (Zoom/WebEx -Camera must be On) and chairs Data Management concerns and issues.
- Reviews and provides feedback to CRO in relation to the Data Management Plan throughout the life cycle of the study protocol, which includes: CRF Annotation, Database Specifications, Data Entry Guidelines, and other pertinent Data Management documents.
- Interacts with Director of Biometrics, Director of Clinical Data Management, Statisticians, Programmers, Clinical Trial Project Managers, and other personnel to provide support in the areas of data management, data validation, database lock, and report generation.
- Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content from CROs as well as other external electronic data transfers.
- Ability to review, comment or if need be, create a Data Transfer Agreement of External data.
- Ability to review and reconcile if need be Serious Adverse Events and Adverse Event data.
- Ability to review coded adverse events and concomitant medication data.
- Ability to review patient profile listings, and laboratory data (e.g., Chemistry and Hematology).
- Ability to review and have experience to review: Tables, Listings, and Figures (TLFs) and provide input when necessary.
- Provide input for existing or new SOPs and other procedural documents to maximize productivity and efficiency with the Biometrics department.
- Maintain an overall knowledge of regulatory guidelines, industry standards, and new technologies.
- Monitors the data management processes for ongoing projects to ensure that work is proceeding in an efficient manner and that projects’ timelines are met.
- Communicates and cc via email, Zoom or phone project status and key project issues to Director, Clinical Data Management
- Communicate back to clinical sub-team of post-mortem investigation of previous studies (e.g., lessons learned) for study design and continuous improvement of new studies.
- Bachelor’s degree or equivalent in life science, computer science, business, or related discipline
- Minimum of 5 years’ experience as a Senior Data Manager working within a pharmaceutical or CRO environment.
- Minimum of 3 years managing external vendors for Data Mgt. in a Leadership capacity.
- Minimum of 2 years of Therapeutic experience in oncology is a must and understanding of RECIST.
- Minimum of 2 years working with Biomarker or External data (i.e., PK, Antibody, Genetic, etc.).
- Understanding the coding process and terms in MedDRA, WHODRUG and CTCAE.
- Thorough knowledge of applicable regulatory rules and guidelines, including ICH.
- Complex understating of clinical trials experience.
- Demonstrated proficiency in the data management processes.
- Possesses excellent interpersonal communication skills (written and verbal).
- Strong attention to detail and ability to work independently
- Minimum 3 years proficiency in the use of clinical database or systems such as Medidata Rave™ and Integrated Review.
- Understanding of CDISC, SDTM, ADAM, and SAS® terminology.
- Proficiency in Microsoft Software (Word, Excel, PowerPoint, & Outlook)
- Possesses a positive attitude and works well with others.
- Ability to work independently in a fast-paced environment and meet results.
How to Apply
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to email@example.com.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.