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Manager of Clinical Compliance Full-time

at Piper Companies in Maryland (Published at 07-01-2019)

DESCRIPTION

The Manager, Clinical Compliance and Business Excellence is responsible for the development and implementation of business processes that support effective, efficient, and compliant study execution. Working collaboratively across the organization and with clinical study team members, the Manager, Clinical Compliance and Business Excellence will construct robust procedural frameworks that reflect a commitment to operational excellence, Good Clinical Practices (ICH/GCP), and regulatory guidelines.

This position will interact regularly with Clinical Operations leadership, Clinical Quality Assurance representatives, and cross functional stakeholders to support process related needs and provide clinical compliance/ best practice expertise throughout all stages of the drug development life cycle. Candidates must have mastered core concepts of drug development, clinical trial execution, clinical outsourcing, and ICH/GCP requirements, as well as must have the ability to prioritize multiple tasks, communicate effectively, and cultivate strong cross functional relationships.

PRIMARY RESPONSIBILITIES

  • In conjunction with the Sr. Director Clinical Operations, work cross-functionally to understand organization needs, perform regular gap analyses, assemble and facilitate process improvement working groups, and drive identified best practice opportunities from conceptualization through implementation
  • Author, facilitate review, and obtain approval for best practice documents, standard operating procedures, and templates while ensuring consistency with ICH/GCP principles
  • Assist in identification, creation, and implementation of future capabilities (i.e. new systems, technologies, and/or efficiencies that enhance the effectiveness of compliant clinical trial execution)
  • Working closely with Quality Assurance counterparts, provide ICH/GCP guidance and Clinical Compliance expertise to all stages of clinical trial conduct, including but not limited to: core document generation, plan development, vendor selection/oversight, trial initiation/maintenance/closure, internal audit response composition, critical issue escalation, and CAPA management
  • Plan, build, and facilitate trainings as needed
  • Work closely with Sr. Director Clinical Operations to prioritize and communicate procedure release dates
  • Assist in the creation and maintenance of ongoing procedure checks and feedback loops
  • Assist in the construction, update, and testing of clinical trial management systems
  • Manage authoring systems as needed, as well as generate, distribute, and oversee process improvement progress reports
  • Generate purchase orders, process vendor invoices, and assist in tracking budgeted spend



POSITION REQUIREMENTS

SKILLS, KNOWLEDGE AND ABILITIES REQUIRED

  • Bachelor?s degree required with an emphasis on Life Sciences
  • At least 5 years? clinical research management experience (e.g. CPM or equivalent) or 5 years? overseeing clinical trial conduct in a ICH/GCP/Clinical Compliance role

TECHNICAL SKILLS

  • Must have mastered principals of ICH/GCP/Clinical Compliance and demonstrates a working knowledge of clinical research and development
  • Must have experience developing and/or authoring best practice documents, guidances, and/or SOPs
  • Demonstrates strong professional expertise and familiarity with industry standards
  • Ability to work in a dynamic, fast paced, team environment


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