Sr. Manager/Associate Director, Data Management

Reporting to the Director, Data Management, the Sr. Manager/Associate Director will act as Data Management expert to develop data management strategies, knowledge related to URL management (on which databases reside), identify technologies to best support projects. The candidate will be responsible for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

• Accountable for data management activities for Kiniksa clinical studies and oversee CRO data management activities that support ongoing clinical programs.
• Provides input to improve data processes and organization in alignment with other development functions.
• Develop and maintain SOPs and working practice documents for data management tasks in collaboration with other functions.
• Participate in the development and maintenance of standard eCRFs and associated edit specifications.
• Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis)
• Lead EDC database (DB) specification process internally and ensure the database is built to capture the protocol schedule and endpoints.
• Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
• Review / Develop Data Transfer Agreement(s) (DTAs) for external analyzable data to be received at Kiniksa.
• Oversee and participate in the User Acceptance Testing (UAT) for all databases related to clinical trial study data in accordance with Kiniksa and CRO SOP's.
• Ensure clinical data within EDC is of high quality to support lock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding.
• Accountable for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective.
• Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
• Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs
• Coordinate and communicate with DB vendors on consistent basis to address Clinical team's requests, project plans, and/or eCRF development activities
• Participates in the preparation and presentation of data, when applicable at internal study team meetings.
• Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
• Familiar with Medidata URL management and maintaining global library.

Qualifications:

• Requires a Bachelor's degree or higher (MS preferred) in relevant scientific field or discipline with a minimum of 6+ years of clinical data management experience in pharma/biotech
• Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company
• Experience working in an outsourced data management model
• Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
• Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management
• Prior experience filing a BLA or NDA preferred.
• Ability to manage multiple initiatives and shifting priorities within a small company environment.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.

• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Salary is commensurate with experience
• Kiniksa Benefits Summary - USA

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.