Assoc. Director, Data Management
$198,000—$210,000
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Posted 37 days ago
SENIORITY
Manager
SALARY
$198,000—$210,000
About the role
- (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
- Review protocols and study strategies to ensure feasible, compliant and effective data collection.
- Lead cross-functional data review and align stakeholders on quality, timelines and risk mitigation.
- 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
- Drive study and program milestones, proactively identifying risks and implementing solutions.
- 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) between external data vendors and/or core labs
- Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
- 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 DBsCoordinate 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
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities
- Set up and maintain task related to building database on Medidata URL and generate listings in Clinical data studio tool for data cleaning.
- Support regulatory submissions, health authority responses, inspection readiness, and audits.
- Standout Skills for Impact: Strategic thinking to align data management with long-term organizational objectives
- Strong communication skills
- Analytical and problem-solving skills to identify data issues and implement solutions
- Oversight and leadership to guide teams, manage projects, and ensure adherence to protocols
- 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
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