Clinical Data Manager

Job Title:          Clinical Data Manager

Reports to:       Vice President, Clinical Affairs

Location:          Dallas, TX – Remote work may be an option for those unable to relocate

 

Position Summary:

Osteal Therapeutics, Inc. 

is a clinical-stage company developing a novel pipeline of drug/device combination therapies for the treatment of musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in Phase 2 comparative trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.

Osteal is looking for a Clinical Data Manager responsible for the quality and accuracy of all clinical data for our current Phase 2 clinical program. Reporting to the VP, Clinical Affairs, the Clinical Data Manager will be a critical member of the clinical team, accountable for all data management activities related to our robust clinical trial program to support Osteal’s current and future products. This is an opportunity for an experienced data manager to play a central role in planning and executing trials that will be critical to Osteal’s success.

 

Essential Responsibilities:

  • Ensure data integrity by establishing appropriate data management processes (e.g. protocol compliance reporting, missing or discrepant data queries, evaluation of data outliers, data quality check, etc.).

  • Work with internal stakeholders and vendors to establish systems to collect, monitor, and manage clinical trial data.

  • Manage custom query requests and reporting from clinical database systems made by the Clinical Affairs department and other internal stakeholders.

  • Develop Clinical Affairs SOPs, best practices, work instructions, tools, and templates related to clinical data management.

  • Work with Clinical Trial Manager to monitor key study and site quality metrics.

  • Oversee the development of CRFs, edit check specifications, and additional data collection requirements for tracking and analysis of key clinical data.

  • Work with other Clinical Affairs functions to review the quality and integrity of the clinical trial data and review data listings for accuracy and completeness.

  • Work with vendors to create and manage necessary data capture and other data management systems.

  • Responsible for validating clinical trial data and preparing locked datasets to support clinical study reporting requirements.

  • Work with the Regulatory and Quality departments to reconcile and report clinical trial serious adverse events.

  • Review relevant clinical study reports to ensure adequate quality control.

Experience/Skills:

  • Bachelor’s degree with at least 5 years of experience with increasing responsibility related to clinical trial data management.

  • Strong working knowledge of FDA and ICH/GCP regulations, and thorough knowledge of clinical data management procedures.

  • Successful track record of managing clinical trial data in all phases of pharmaceutical and/or medical device clinical trials.

  • Experience in orthopedics preferred but not required.

  • Extensive experience in using and managing EDC and other data management systems from external vendors.

  • Experience in working with and managing external vendors.

  • Self-starter with good written and oral communication skills.

  • Ability to multi-task and prioritize tasks according to trial needs.

  • Willingness and ability to travel regularly (up to 20%).