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Manager of Clinical Research Compliance

Job Attributes

Job Id:

18376

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated Manager of Clinical Research Compliance to support clinical research study compliance initiatives and development for a Research Company in Rockville, MD.  The Compliance Manager will support ongoing rare disease and genetics studies.

 

Responsibilities for the Manager of Clinical Research Compliance:

  • Interact regularly with Clinical Operations, Clinical Quality Assurance, and cross functional departments to provide clinical research compliance expertise throughout all stages of the drug development life cycle
  • Work cross-functionally with research departments to identify compliance improvement needs, assemble and drive identified compliance best practice opportunities from concept to initiation
  • Develop SOP documents and templates for compliance initiatives while adhering to ICH/GCP regulations
  • Assist with identification and implementation of new systems, technologies, and processes that enhance the compliance for ongoing research studies
  • Working closely with the Quality Assurance Department to provide regulatory (ICH/GCP) guidance for activities like document generation, study plan development, vendor selection and oversight, trial initiation, monitoring and close-out, internal audit response, event escalation, and CAPA management
  • Assist in the development and amendments to procedure checks and feedback loops
  • Assist in the development and maintenance of clinical trial management systems
  • Create purchase orders, process vendor invoices, and assist in tracking budget spending

 

Requirements for the Manager of Clinical Research Compliance:

  • 5+ years of Clinical Research Compliance Project Management experience
  • Expert knowledge of ICH/GCP guidelines
  • Bachelor’s Degree in Science-related field

 

Compensation for the Manager of Clinical Research Compliance:

  • Salary up to $125,000 based on meeting of requirements
  • Benefits: Health, Dental & Vision Insurance, 401K, Paid Holidays

 

Please send all qualified resumes to: idusci@pipercompanies.com

 

 

Keywords: Clinical Research Compliance, data management, FDA, Food & Drug Administration, clinical research, clinical trials, specimen tissue, clinical documentation, informed consent, IRB, GCP, good clinical practice, SOP’s, cardiovascular, cardiology, pulmonary, Parkinson’s disease, infectious disease, HIV, AIDS, research, study coordination, EPIC, CTMS, ECD, aerodigestive, head, neck, lung, cancer, hematological, malignancy, leukemia, blood cancer, project manager, project management, study portfolio, investigator initiated study, ITT, investigator initiated trial, study initiation, ICH, Project Manager, CPM, Clinical Project Manager. SOP, clinical operations, QA, Quality Assurance

 

 

 

 

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New Search

Job Id:

18376

Job Category:

Clinical & Life Sciences

Job Location:

Rockville, MD  20850

Security Clearance:

No Clearance

Business Unit:

Piper Companies