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Clinical Trial Lead IV

Fort Worth, TX 76134

Posted: 01/04/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 530589 Pay Rate: 89.29 Is job remote?: No Country: United States

Job Description


Job Purpose
  • Accountable for all aspects of assigned clinical trials for Post-market Clinical Follow-up (PMCF) required by European Union Medical Device Regulation (EU MDR).
  • Oversee a Clinical Research Organization (CRO) running the Clinical Trial Team. The CRO is responsible for planning, conducting and reporting on assigned PMCF clinical trials.
  • Oversee the development of protocols, ensuring scientific rigor and quality.
  • Oversee the clinical trials to ensure they are conducted with efficiency, quality, on budget and on time.
  • Elevate significant issues to CRD Leadership.


Major Accountabilities
  • Oversee the CRO that is running a group of clinical trials for PMCF required by European Union Medical Device Regulation (EU MDR).
  • Acts as the Liaison between the CRO and the company CRD for a book of work.
  • Report status of all PMCF clinical trials to CRD. Prepare slide decks and present at Study Review Meeting for PMCF Clinical Trials.
  • Elevate significant issues to CRD Leadership. Lead resolution of elevated issues.
  • Define clinical outsourcing specifications and scope of work for clinical trial vendors.
  • Oversee CROs conduct of tasks and development of key deliverables such as protocol, database, protocol monitoring plan, statistical analysis plan, informed consent template, deviation and evaluability plan, site and patient recruitment plan, data review plan and communication plan.
  • Execute Statement of Work between CRO and the company for each clinical trial.
  • Accountable for accuracy of trial information in trial tracking systems.
  • Ensure Health Authority and IRB/IEC submission and approval.
  • Independently ensure quality and timely execution of a clinical trial within timeline and budget.
  • Manage CRO clinical trial budget and monthly accruals.
  • Ensure data is reported to the company in a timely manner, in an agreed upon format.
  • Ensure reporting of results to the company CRD and Core Team.
  • Oversee authoring, review and approval of the Clinical Study Report.
  • Ensure archiving of trial master file and other relevant documents at end of study.
  • Responsible for implementation of best practices and standards for trial management with CROs, including sharing lessons learned


Qualifications:
  • Bachelor's degree in life science; Medical, pharmaceutical, biology, chemistry degree preferred.
  • 5 years in clinical research or relevant scientific, industry, therapeutic or geographic experience
  • Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies
  • Experience managing or working at a CRO
  • Knowledge of EU MDR Requirements for PMCF

Pay ranges between $60-90/hr **salary will be commensurate with experience**
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