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Senior Clinical Data Manager

3 months ago

Cambridge, United States Prometrika LLC Full time
Job DescriptionJob Description

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.


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

EDUCATION

  • Minimum BS in a scientific or health related field or equivalent

EXPERIENCE

  • Minimum 9 years of experience in Clinical Data Management

SKILLS

  • 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

PHYSICAL REQUIREMENTS

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.