The candidate will be aligned with four fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
Landos Biopharma is an emerging clinical-stage biotech company looking for a highly motivated individual with an A+ attitude to help manage agile/lean operations. The Clinical Data Manager must be able to manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all study-specific protocols. A successful candidate will be a motivated, self-starter with proven ability to follow through. A wide degree of creativity and latitude is expected. Must have excellent oral and written communication skills.
- The Clinical Data Manager (CDM) is responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams at Landos and interface with external CROs and external vendors to fulfill many of his or her responsibilities, as follows:
- Develop and implement methods to demonstrate oversight of CROs and other vendors, and manage and/or monitor the progress of outsourced data management activities
- Provide direction and leadership in CRO and vendor selection and management.
- Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Protocols, Centralized Monitoring Plans, Statistical Analysis Plans, etc.) and trial conduct
- Perform Study Start-up
- Prepare or review draft Case Report Forms (CRFs)
- Prepare draft of CRF Completion Guidelines
- Prepare draft of Data Management Plan (DMP) and Edit Check Specifications
- Prepare draft of all applicable database design specifications
- Prepare draft of User Acceptance Testing (UAT) Plan
- Perform UAT on the database/user roles/edit check specifications and compile the UAT package
- Review draft CRF Annotates and Database Specifications
- Perform Data Management Review
- Perform discrepancy management by effectively utilizing the DMP and Edit Check Specifications to review the data for overall consistency and accuracy
- Perform manual review/QC checks as listed in the Edit Check Specifications using applicable browser or reporting tools
- Perform vendor data reconciliation with applicable clinical database (e.g., IVRS, laboratory data, SAE)
- Perform query processing/resolution
- Track all DM issues and ensure proper resolution by study completion
- Identify data trends and report study inconsistencies to applicable study team personnel and work together to develop and implement an action plan
- Be responsible for and manage data management activity of Clinical Data Managers assigned to his/her trials
- Ensure that the Data Management component of the TMF and other documentation required to support regulatory submissions and inspections are maintained to the standard required
- Coordinate closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Drug Safety, Project Management and Regulatory to ensure operational excellence.
- Contribute to strategic planning to ensure optimized use of data management resources within the area of responsibility
- Provide vision, leadership, and mentoring to staff assigned to his/her line management
- Participate in and/or lead the development and implementation of standards and processes related to both clinical data and risk-based trial management
- Participate in the generation and approval of budgets and timelines
- Undertake rigorous and meticulous data analysis
- Build, develop, enhance and maintain data models, reporting systems, data automation systems, dashboards, analytic templates and performance metrics that support key business decisions
- Manages and optimize processes for data intake, validation, mining and analytics as well as modeling, visualization and communication deliverables
- Coordinate, gather and provide member survey direction to obtain additional data. Integrate after-survey data with current multiple sources.
- Consult with partners to identify and define business requirements and translate business needs into complex analytics and recommendations
- Partner throughout the organization to give direction on the development of predictive models based on demographic, psychographic, econometric and statistical data that deliver insights related to member engagement and provide direction based on priority drivers
- Partner to lead advanced analytics and data science projects including understanding strategies to make recommendations on how to apply data science methods to achieve business goals
Required Knowledge, Skills, and Abilities
- 5-7 years as Clinical Data Manager
- Thorough knowledge of data management and its role in the drug development process
- Understanding of the contributions of other functions critical to the execution of clinical trials, and their interactions with data management
- Experience of all stages of a clinical trial and vendor oversight
- Experience of managing and mentoring clinical data managers
- Demonstrated knowledge of ICH/GCP guidelines as they relate to data management
- Thorough understanding of CDISC CDASH and SDTM standards
- Extensive experience managing CROs and other data vendors.
- Experience working with a globally distributed team
- Ability to work on and solve complex problems.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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