Reporting to the Senior Director, Biostatistics, the Associate Director will serve as a strategic data management leader across clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. The Associate Director, Clinical Data Management ensures optimized data collection, flow and access across EDC and non-EDC data sources.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
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
- 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 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
- 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
Qualifications and Experience: - 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
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$198,000-$210,000 USD
