LOCATION: South San Francisco
DEPARTMENT: Clinical Operations
DIVISION: Product Development
REPORTS TO: VP, Clinical Operations
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages.
Effective Date: February 2021
The Clinical Data Manager is accountable for Clinical Data of clinical and non-clinical data for Day One-sponsored trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversee clinical data management activities across multiple studies, prepare DM minutes, agendas, data process flow maps and internal timelines
- Assist in the design of the eCRFs and ensure that they conform to company and industry standards
- Supervise vendors that have been contracted to handle trial data (e.g., EDC and IRT vendors, CROs, Labs, etc.) and ensure the data are complete, accurate and delivered within the timelines agreed to
- Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans.
- Perform User Acceptance Testing (UAT) on development of EDC and IRT systems
- Contributes to the company’s long term data generation and management strategy
- Ensure data transfer specifications are in place and review data transfers for consistency with company data standards and SDTM specifications
- Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
- Perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document, data plans and as requested by the clinical team.
- Participate in reviews of TFL output prior to final database locks
- Ensure that all data management documentation have been collected and uploaded to the relevant sections of the working files on the server and the study TMF
- Report query trends and data/query metrics and oversee suggest any changes, additional training as appropriate
- Prioritize projects and coordinate data management activities in support of corporate goals and objectives
- Assess and help address data management resource needs as the trial, projects and pipeline advance, and the company grows
- Contribute to departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
- Address the business needs of CDM functional customers
- Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership.
- BS/BA degree in related discipline; or,
- Advanced degree in related discipline; or,
- Certification in assigned area
- 4 or more years’ experience of programming of clinical data with a biotech or pharmaceutical company, including solid experience in database creation or data analysis
- Experience in SAS programming is required
- Experience with Tableau, R, Python or any other languages or software is a plus
- High level of proficiency in SAS Base, SAS/STAT, SAS Graph and SAS Macro Language
- Good knowledge of medical and statistical terminology
- Good understanding of the specific data management problematics encountered in rare diseases/pediatric drug development
- Strong background in using MS Excel
- Applications building knowledge and expertise
- Understanding of validation process for applications
- Excellent organizational, problem-solving, and analytical skills.
- Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.