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Associate Manager, Clinical Trial Management

Employment Type Temporary
Field of Work Clinical/Medical

 

Position Summary

Assists the Clinical Operations Franchise Head in customizing existing operational plans for the study/program for multiple clinical vendors in order to achieve IND/BLA/sBLA applications and maintain inspection readiness.   Participate and contribute to initiatives to drive continuous improvement and delivery of business technologies that are operational in a study/program/franchise. Assists Global Clinical Project Leads (CPL) by tracking compliance to all study level plans and escalating any variances. This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways.

Principal Responsibilities

  • Customize/update any portfolio level plans or process flows to the study/ site level in collaboration with the CPLs and the CRO teams, as appropriate such TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release documentation collection plan etc.
  • Serve as a system expert for the implementation of any business technologies that are operational in a study/franchise throughout the study’s life cycle.
  • Generate and maintain study essential documents checklist, IP release documentation and proactively ensure study document submission to the eTMF throughout the study’s life cycle.
  • Coordinate study team training in the investigator portal; monitor site/CRA user access and track training compliance during the course of a study especially around staff changes or protocol changes.
  • Deliver CRA training on business technologies/applications that are operational in a study.
  • Responsible for ensuring registration of a protocol in ClinTrials.gov and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP.
  • Participate in sponsor operational team meetings with the CRO, Data Management, Regulatory Affairs, CQA and Clinical Supplies and document escalations and actions around training, TMF, IP release Clinical Trial Registry documentation.
  • Participate as a SME in the implementation of various Clinical Operations initiatives in conjunction with the CoE as required. Ensure consistent implementation of best practices across all studies in a franchise.

Qualifications

  • 4 years clinical research experience in the pharmaceutical industry.
  • Solid understanding of software capabilities and business applications.
  • Good oral and written communication and interpersonal skills
  • Knowledge of clinical trial practice and processes with ability to present systems/application requirements for business system design.
  • Proven ability to manage and prioritize multiple tasks remaining focused on personal objectives and working effectively in a multi-disciplinary team or independently when required.
  • Mentor and lead junior staff to share their vision and support them to reach a common goal
  • Work with CROs and vendors to drive accountability.
  • CCRP certification. Bachelor’s degree is preferred.

Competencies

  • Accountability-Holds self and vendors accountable for delivering results
  • Collaboration- Fosters open dialog between CRO/COL/CPL and data management to ensure quality deliverables. Creates stable relationships with clinical trial sites during study start up to foster an environment where site staff help meet study initiation time lines.
  • Problem Solving-Can see hidden problems and escalate as needed.
  • Dealing with ambiguity- Can decide and act without having the total picture.
  • Written Communications- Is able to write clearly and succinctly in a variety of communication settings and styles.
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