Senior Clinical Data Manager, Clinical Data Science

Ionis Pharmaceuticals, Inc.•Boston, MA

114d•Hybrid

About The Position

The Senior Clinical Data Manager is responsible for all aspects of clinical data management throughout study conduct. The Senior Clinical Data Manager executes on policies and procedures for gathering, analyzing, and reporting clinical data for clinical trials that are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements.

Requirements

Bachelor’s Degree (BA/BS) preferred
Minimum of five (5) years of direct Clinical Data Management experience, including at least 2 years of Study Lead Data Manager responsibilities.
Experience with Electronic Data Capture (EDC) systems
Working knowledge of CDISC CDASH and CDISC SDTM standards/guidelines
Experience/training in the following areas: Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview
Proficiency in MS Office including Word, Excel, and PowerPoint required

Nice To Haves

Medical coding experience preferred but not required

Responsibilities

Acts as lead data manager within study team
Performs/oversees database development and management (e.g., CRF Specifications, Edit Check Specifications, Programming Specifications and QC, User Acceptance Testing, open, clean and lock of databases)
Support the adoption and implementation of Clinical Data Warehouse technology to enable streamlined CDM data review strategies
Implement Risk Management Planning on clinical studies
Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Manual Review Guidelines)
Manages and performs ongoing data management activities including CRF review, query generation, receipt and reconciliation of external data, SAE reconciliation, data listing generation and production of CDM summary reports (e.g. metrics) within projected study timelines.
Performs medical coding of data using MedDRA & WHODrug dictionaries
Ensures clinical data management activities are executed in compliance with regulatory authority requirements and Good Clinical Practices (GCP)
Evaluates issues, recommend and implement solutions mitigation strategies as required
Assists or leads with vendor selection process for outsourced CDM activities
Oversees, as necessary, multiple External Service Provider (ESPs), contractors, or direct reports engaged to perform data management and EDC activities
Participates in governance of External Service Provider (ESPs) across studies
Participates in training of new hires and/or junior team members
Supports regulatory inspection activities
Oversees external data providers (e.g., IRT, central and specialty labs, patient diaries)
Presents at investigator’s meetings and other data management trainings for study
Escalates study related issues and communicates as appropriate with management and other functions
Represents Clinical Data Management at study team meetings and facilitates cross-functional activities (e.g. Clinical Data Listing Reviews, database lock activities)
Proactively addresses operational issues and clinical data questions
Provides updates on study timelines, vendor oversight and other study related activities
Liaises with the document specialists to ensure data management files are filed appropriately
Implements best practices and industry standards across all data management activities
Assists and leads department initiatives, process improvements, and cross functional initiatives
Performs other duties, as appropriate
Travel is variable and estimated at 10-20% domestic and international