The role of head of Clinical Data Management is a leadership role for the Clinical Data Management function, including determination of systems and processes, resourcing plans, and oversight of outsourced activities.
This is an exciting time of growth for our company with a significant number of ongoing and planned clinical trials supporting multiple investigational agents in the pipeline followed closely behind by new investigational agents from internal research platforms. The successful candidate will report to the VP, BPDM and join the BPDM leadership in building a world class team of clinical data science professionals.
- Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
- Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
- Ensures the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks
- Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
- Identify suitable vendor(s) for outsourcing data management activities and coordinate the review and approval of contracts
- Work closely with CROs to prepare and ensure proper development and execution of data management plans
- Reviews protocols to ensure database feasibility
- Ensures that eCRFs, database interfaces, programmed edit checks and external data files are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and possible regulatory submissions
- Runs and reviews edit checks and resolves discrepant data
- Responsible for development of CRF completion guidelines and for EDC training at Investigators' meetings and for other internal and external project members as needed
- Manages coding dictionary subscriptions and integrates coding dictionaries within the EDC (e.g., MedDRA and WHODrug)
- Designs and implements metrics reports summarizing data completeness (e.g. lag), monitoring progress, queries outstanding and query aging
- Collaborates with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization dashboards
- Supports biological sample reconciliation and SAE reconciliation
- Represents the data management function on study teams
- Responsible for resourcing the data management function in support of clinical development plans
- Defines and implements documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is in an audit-ready state
- Maintains study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial
- Ensures that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
- Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.), including global, harmonized SOPs and specific quality processes and procedures for Data Management
- Ensures that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements
Education & Experience:
- Bachelor’s degree in statistics, computer science, mathematics, life sciences or relevant field
- 10+ years of experience in Clinical Data Management and/or technology integration in the pharmaceutical industry
- Knowledge of FDA/ICH guidelines and industry standard practices related to Clinical Data Management
- Previous experience in managing multiple direct reports is a must
- Experience with (s)NDAs, BLAs, and MAA’s is a must
- Previous experience with CDM systems including EDC and sound understanding of EDC build and integration concepts
- Demonstrated record of fostering creativity, productivity, and execution with urgency, teamwork and accountability
- Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives consistent with AnaptysBio culture
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car.
This position requires working with biological and/or chemical hazards.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
$150k-$193k,20% bonus,10% 401k, Stock Options&RSU