Sr. Clinical Data Manager

Health Decisions Cro+ Durham , NC 27701

Posted 5 months ago

Overview

Health Decisions is a specialty CRO that utilizes a broad expertise across Women's Health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwide. We are seeking a Senior Clinical Data Manager who will lead the development and implementation of clinical data management project deliverables according to Standard Operating Procedures (SOPs). Responsible for the collection, integration, validation, cleaning and management of subject trial data.

Responsibilities

  • Conducts study start up, maintenance and close out DM activities

  • Complete data entry activities as necessary

  • Manages coding activities

  • Trains monitors and site coordinators in correct CRF completion

  • Troubleshoots proprietary data management software

  • Works actively in project team environment by:

  • Participating in internal and client meetings

  • Reporting project status to project /functional management

  • Proposing solutions for procedural and technical issues

  • Mentoring and training other staff members

  • Service as functional project manager for one or more projects

  • Adhering to financial and administrative processes such as managing project budget and timelines, estimation of resource needs and projected hours

  • Communicating effectively with sites and site monitors to process queries from generation to resolution

Qualifications

The successful candidate will hold a BA/BS degree with at least two years of data management experieince in a medical device, pharmaceutical or CRO company. Experience using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. Progressive experience in data management activities in the clinical research industry. Working knowledge of Good Clinical Practices, Good Data Management Practices, Clinical Research, Clinical trial process and related regulatory requirements and terminology. Working knowledge of Clinical database applications such as EDC and CTMS. Proficient computer skills, especially MS Office.

Health Decisions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


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Sr. Clinical Data Manager

Health Decisions Cro+