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Clinical Study Associate

Planet Pharma


Location:
Collegeville, Pennsylvania
Date:
04/18/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Planet Pharma
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Job Details

Summary:

  • Support the successful migration/indexing of clinical study trial Master files into the new eTMF system (Pharma TMF) through the provision of support to the CPSSO Study Accountable Person (SAP) and their Study Team members e.g. Clinical Development Scientists and Clinical Data Scientists (as appropriate)) to agreed quality and data integrity standards.
  • Provide support to the CPSSO clinical development or data scientist team members as needed (e.g. instream review of data, drafting and preparation of documents etc.) to support their TMF migration/indexing and study deliverable targets.
  • Serve as point of contact for the migration/indexing study teams for TMF matters, and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated and indexed TMFs are inspection ready
  • Support the analysis and identification of business problems/opportunities that may arise during the migration/indexing and, support the implementation of high quality solutions
  • Address requests in a timely and efficient manner
  • May assist in the development and delivery of training materials providing subject matter expertise and know how

Requirements:

  • Knowledge and experience of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes
  • Knowledge of Trial Master File industry accepted standards, such as the DIA’s TMF Reference Model
  • Knowledge of electronic document management applications (e.g., Documentum, SharePoint, Livelink)
  • Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records
  • Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders
  • Proven record of being customer driven and providing effective consultation and training
  • Self starter, able to work in independence as well in matrix team environment
  • Analytical / logical, with superior attention to detail and an inclination to spot patterns and outliers
  • Bachelors Degree in a scientific discipline
  • Minimum of 3 years experience from a CRO or Pharma working in clinical research, clinical operations or data scientist roles (eg Study Manager, Clinical Research Scientist, Clinical Data Scientist, Data Manager and/ or in records management).

Requirements

Required experience:

  • records management: 3 years
  • Clinical Research: 3 years
  • clinical development: 3 years
  • TMF systems (paper and electronic): 3 years
  • Documentum, SharePoint, Livelink: 3 years
  • ICH/GCP regulations: 3 years