Director, Head of Clinical Data Management

Full Time On-Site/Hybrid Data Management Data Management Director Apply for this Job 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.

Essential Functions

• 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

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

Salary Description: $150k-$193k,20% bonus,10% 401k, Stock Options&RSU