Data management Jobs in Cambridge, MA

Company Summary : Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro's lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.

We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.

Position Summary :

Reporting to the Chief Medical Officer, the Director, Clinical Data Management supports the Clinical Development organization by providing expertise in all aspects of clinical data management for assigned study(ies). The person in this role will participate with both strategic and hands-on support, oversight of vendors / CROs, and contributions to departmental process and standards development

Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment.

Key Responsibilities :

• Manage all data management (DM) tasks for clinical programs from study startup through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.
• The person in this role must have experience in a regulated environment and be prepared to present data and documentation in support of regulatory requirements for complete and accurate data.
• Establish Data Management function at Korro and author, review, publish, and review policies and methods in standard operating procedures, work instructions, job aids, and other training documents.
• Work closely with cross-functional members of the study team including Clinical Development, Biostatisticians, Statistical Programmers, Pharmacovigilance, Regulatory, Translational Research and Clinical Operations.
• Provide representation, and guidance to the internal and external teams as the clinical data management subject matter expert for assigned program / studies.
• Serve as a subject matter expert for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
• Oversee CRO data cleaning activities including processing queries, performing ongoing data review, identifying and tracking data issues and trends to give transparency to Global Development Program Leads, and other program team members.
• Provide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and management.
• Map data flows, processes and systems used for collection, management and provision of data to downstream functional area users.
• Contribute to data management deliverables including Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, Lab Specifications, etc.
• Support vendor UATs for database builds and or migrations to manage any impacts from mid-study updates to the EDC database.
• Meet with global regulatory agencies and mock auditors in quality, performance, and system audits and inspections and ensure inspections meet department performance metrics through pro-active compliance and quality measures.
• Develop data management standard working practices along with preparations and requirements for regulatory submissions and inspections.
• Establish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure transfers are executed to plan.
• Reconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and / or oversee study data reconciliations performed by the CRO.
• Assume ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures.
• Coordinate with CRO on presentation of data metrics, trending and reports for data review meetings with internal stakeholders to ensure ongoing data integrity and proactive quality measures are employed to identify data issues.
• Assist in defining data listings, summary table validation, data specifications and / or process data transfers in preparation for statistical review and / or data management audits.
• Support close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Contribute to data system compliance by following the established guidelines of national and international regulatory authorities.

Qualifications :

Benefits : Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.