layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Assoc. Director, Data Management at Kiniksa Pharmaceuticals | LAYIQ

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

Assoc. Director, Data Management

Employer job description

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Qualifications and Experience:

Equal opportunity and accommodations

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