PRA Health Sciences

Independent Drug Monitoring Manager

United Kingdom, France, Italy, Netherlands, Poland, Belgium, Home based
12 May 2021
11 Jun 2021
Full Time
Contract Type
Experience Level

This service provides global coordination for the execution for unblinded drug management, including the general facilitation of the Independent Drug Monitoring process between the Independent Drug Monitoring Team (IDM Team) and the Clinical Trial Team.  Ensure IDM deliverables progress according to agreed upon timelines and in support of trial milestones; providing status updates, as required.   Ensure inspection readiness through compliance with company Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), applicable other applicable regulations and guidelines from start‐ up through close‐out. Takes ownership for assigned IDM responsibilities. Advanced services are more complex and/or have a greater potential impact on business results. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non‐trial project work.

You Will:

  • Comply with relevant and on‐time training requirements.
  • Lead study teams in management of IDM related processes and operations; ensuring blind.
  • Provide input for the development of pharmacy related materials, including forms and manuals.
  • System set‐up including IVRS and EDC in a supportive capacity.
  • Ensure adherence to quality of the IDM process, including, translation, documentation, and escalation of major/critical issues in a blinded manner; follow up appropriately to closure.
  • Act as the main point of contact for resolution of any ad‐hoc questions associated with IDM issues.
  • Resolve and document urgent/critical unblinded and pharmacy‐related issues and investigate trends.
  • Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process.
  • Provide updates to Trial Team on pharmacy‐related and compliance issues in a blinded fashion.
  • Take initiative to suggest and implement solutions to site‐level issues.
  • Oversees Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites. Primary point of contact for the IDM.
  • Provide communications and necessary information to IDMs on study updates, such as protocol amendments Potential of to co‐monitor IDMs.
  • Review IDM monitoring visit reports (initiation, periodic & close‐out) and provide feedback, as needed.
  • Provide back‐up and support for the IDM.
  • Provide training & re‐training to new IDMs and site pharmacy staff.
  • Ensures IDM visits occur within window and ensure any out of window visits are tracked per process.
  • Ensures IDM monitoring visit reports and issue logs are up‐to‐date
  • Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans.
  • Provide input in audits and/or CAPAs.
  • Assist in database lock/interim analysis; cleaning unblinded data and reviewing unblinded queries, if applicable.
  • Create appropriate trial‐specific IDM training materials and requirements.
  • Establish and maintain excellent working relationships with internal and external stakeholders.
  • Maintain Blinded TMF and perform document management activities.
  • Provide feedback to and train/coach/guide junior colleagues as needed.
  • Work proactively to increase global awareness of IDM processes; train and educate
  • Comply with relevant and on‐time training requirements.
  • Contribute to IDM process improvement and training, as applicable.
  • Lead and/or participate in special initiatives, task forces or non‐trial project work, as assigned; typically, in Advanced.
  • Advanced services:
    • Coach and/or mentor less experienced IDMMs.
    • Assigned more complex projects and/or assignments that have a greater potential
      impact on business results.
    • Autonomy in role.
    • Depth of knowledge of IDMM services.

You Are

  • Bachelor’s or University degree; or equivalent, in appropriate scientific or business discipline.
  • 3‐5 years of relevant experience in clinical trial operations in the pharmaceutical industry or CRO. Advanced: 5+ of relevant experience in clinical trial operations in the pharmaceutical industry or CRO required; advanced degree.
  • Experience in Project Management mandatory; knowledge of databases and/or project
    management systems.
  • Previous work in an international environment.
  • Strong working knowledge of ICH‐GCP, local laws and regulations.
  • Effective leadership skills and ability to manage multiple stakeholders.
  • Experience and ability in coordinating teams in a virtual environment.
  • Proven ability to foster team productivity and cohesiveness.
  • Independent complex decision making.
  • Solution oriented and proactive risk identification and mitigation.
  • Strong IT skills, including knowledge of standard Industry systems and Microsoft applications; willingness to learn new systems.
  • Monitoring experience is recommended; other relevant experience should be considered.
  • Willingness to travel locally/domestically.
  • Proficient in speaking and writing local country language and English.
  • Effective verbal and written communication skills.
  • Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
  • Experience in developing presentations and presenting key information to stakeholders.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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