Senior Clinical Data Manager

Prometrika LLC•Cambridge, MA

About The Position

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

Requirements

Minimum BS in a scientific or health related field or equivalent
Minimum 9 years of experience in Clinical Data Management
Knowledge of medical terminology and pharmaceutical notation
Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
Excellent organizational and time management skills
Strong collaboration and leadership skills

Responsibilities

Responsible for all Data Management tasks from study start-up to database lock for assigned studies.
Lead multiple large and complex studies, performing and delegating tasks as appropriate.
Effectively interact with sponsors and manage vendors.
Mentor junior personnel.
Develop SOPs and study-specific procedures.
Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies
Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules
Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming
Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
Troubleshoot technical issues as appropriate
Design “smart” listings and study-specific processes for effective data review, query issue and resolution
Manage queries and trends to ensure data completeness and integrity
Perform coding of adverse events, medical conditions and medications.
Perform SAE reconciliation
Lead and perform pre-lock and data lock tasks
Prepare training materials and user guides for EDC data collection tools, deliver user training
Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate
Design, generate, and review status metric reports, identifying and communication trends as needed
Ensure archiving of study databases and related documents
Organize and file study documentation
Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies
Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
Provide study specific training for team members and end users, as appropriate
Implement technical solutions, new tools, and resolve complex issues
Lead large and complex projects
Lead client and team meetings as required
Delegate tasks as appropriate, providing mentorship and following through completion
Interact with sponsors and manage vendors for complex studies
Assist with identification of project scope changes
Present at sales and marketing meetings for prospective clients
Develop SOPs and manuals