Clinical Quality Specialist/Coordinator

Planet Pharma Waltham , MA 02154

Posted 3 days ago

Overall a clinical R&D Quality Assurance (R&D QA) support role for routine activities of R&D QA clinical study support and Good Clinical Practice (GCP) Inspection Readiness and Auditing Activities. The purpose of this role is to provide support to the Risk Assessment Lead and ongoing R&D Quality Assurance Activities coordinating documentation review, report reviews, and general documentation activities. Responsibilities may include:

  • Facilitation and support of Clinical Program activities related Inspection Readiness

  • Support CAPA, Audit Planning and infrastructure development activities and harmonization

  • Coordinate meetings, documentation reviews and facilitate action items related to planning activities and infrastructure development for R&D QA processes through the company and Assist in harmonization activities

  • Support clinical audit activities for internal and external audits (i.e. qualification and for cause audits) and clinical trials' teams to ensure total compliance to applicable rules & regulations (study protocols, internal regulations, national & industrial regulations, and so forth)

Requirements:

Qualifications & Experience

  • Minimum 5 years of relevant experience in research or clinical Pharmaceutical or Device Industry with significant role in documentation coordination

  • Strong knowledge GCP in clinical research activities (US, EU and ICH E6 (R2) GCP)

  • Experience with Rare diseases or with vulnerable population in clinical studies of drugs and devices

  • Experience revising SOPs and complex study documents

  • Experience Managing project activities, documenting meeting decisions and actions, and facilitating completion of actions

  • Experience in clinical operations or Clinical Quality (clinical research and/or hospital staff) preferred

  • Experience in Inspection Readiness or Audit oversight preferred

Skills & Competencies

  • Works well independently and in groups

  • Takes direction and completes tasks with little supervision

  • Demonstrated knowledge of risk management tools

  • Excellent organizational skills and strong attention to details

  • Works precisely as per procedures, rules and regulations

  • Great "Can-do" Attitude

Type:Temp/ContractLocation:Waltham, MA


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Clinical Quality Specialist/Coordinator

Planet Pharma