Clinical Data Manager

About the role

The candidate will manage design, development, implementation, validation, maintenance, and support clinical databases related pre-market or post-market clinical studies/registries. The candidate will be responsible for adhering to the required departmental operating procedures regarding Data Management for clinical investigations.

Responsibilities

• Develop project specific data management plan that includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines.
• Understand CRF design and interpret protocol requirements to efficient EDC design.
• Create clinical databases design specifications including edit check specifications.
• Experience with validation of EDCs at a study level including experience developing study requirements, test scripts, and UAT documentation.
• Administration of existing EDC systems for multiple studies simultaneously.
• Provide clinical data management support for study operations and analysis groups including the following:
  • Aid in defining and creation of data listings, including programming software to generate listings.
  • Data specifications and/or process data transfers in preparation for statistical review.
  • Training users on EDC systems. Includes create of training documentation and running training sessions for end users.
  • Data cleaning and review of clinical data. Including query management and data listing review.
  • Manage post-go live issues and requests.
  • Manage activities for multiple studies simultaneously in a dynamic environment.
  • Contribute to development and/or maintenance of departmental operating procedures for data management.
  • Proactive in understanding company needs/objectives and able to independently seek solutions.
  • Works on significant and unique issues in critical situations and able to provide solutions proactively.

Qualifications

• Minimum of 3-5 years of data management experience with a proven track record working in a medical device/pharmaceutical industry.
• EDC system(s) experience (Preferably Medrio and Medidata Rave).
• Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.

Education and Training

• BSc/BA in a scientific or medical field.

Work Conditions

• None

Preferred Skills and Experience

• Desired to have experience with SAS software.
• Desired to have medical knowledge as pertaining to medical devices for surgery.
• Excellent Interpersonal skills.
• Work well in a team environment.
• Work independently to carry out tasks with minimal guidance.
• Effective written communication and interpersonal skills.