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Medical Device Regulatory Affairs Coordinator
Medical Components, Inc. has an opening for Clinical Data Manager in Harleysville, PA.
Responsible for the following duties:

  • Support clinical data management, electronic data capture, electronic trial master files and related technologies and activities pertaining to clinical data gathering and management;
  • Engage and monitor vendors to ensure operations supporting clinical systems are configured in accordance with protocol and applicable regulations;
  • Lead configuration and management when those systems are brought in-house;
  • Aid clinical affairs department in the creation of Standard Operating Procedures (SOPs), study-specific documentation, data reports and acts as a subject matter expert for the department;
  • Proactively engage with and manage the activities of outsource vendors with respect to the selection, configuration and deployment of the following: EDC, eTMF, ePRO, reporting packages, CTMS/Project tracking systems and other clinical data operations systems as required;
  • Advise the department on best practices in data management and execute in the development of compliant and efficient related processes;
  • Serve as main point of contact for meeting internal data report requests in a timely fashion;
  • Responsible for training of internal personnel, and where necessary, external users;
  • Assist remote and traditional monitoring by identifying missing and questionable data and site activities and prepare lists of data to be reviewed with sites as needed;
  • Perform query analysis and communicate query resolution expectations and needs;
  • Ensure sites adhere to protocol as well as local and national regulations and that Medcomp clinical activities are done in accordance with applicable SOPs;
  • Responsible for the trial master file creation and maintenance;
  • Assist with protocol development and study specific documentation;
  • Assist with report development for internal purposes and to meet regulatory requirements;
  • Assist with SOP and Clinical team infrastructure development and implementation;
  • Telecommuting permitted from anywhere in the U.S.
  • Bachelor’s degree in Health Informatics or a related Health Science field.
  • Must have two (2) years of experience configuring and managing EDC systems.
  • Must be knowledgeable of the following: (1) Good Clinical Practice (“GCP”) guidelines from both the International Conference of Harmonization (“ICH”) and the Food and Drug Administration (“FDA”); (2) HIPPA requirements; (3) European Union General Data Protection Regulation (“EU GDPR”) as they pertain to the design, conduct and data handling in clinical research studies; (4) MS Office.
$85,000 to $100,000 per year.

Please email resumes to:
Human Resources Attn: Marcy Kromdyk at with job title Clinical Data Manager in subject line.