Clinical Project Manager/Clinical Operations Lead

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Sona***********

  • United Kingdom
  • Last Update: 03.07.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
London, GB
Country
United Kingdom

Category


Clinical and medical development

Description


Job Responsibilities

  • Acting as the Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
  • Being responsible for project management of the assigned studies: pro-actively planning, driving, and tracking execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
  • Reviewing Monitoring Visits Reports and escalating performance issues and training needs to CRA manager, functional vendor, and internal management as needed.
  • Performing Quality control visits as required.
  • Leading local study teams to high performance: training other local roles in protocol, closely collaborating with and supporting CRAs as protocol expert, and coordinating activities across the different local country roles ensuring a strong collaboration.
  • Creating and executing a local risk management plan for assigned studies.
  • Ensuring compliance with CTMS, eTMF, and other key systems in assigned studies.
  • Escalating as needed different challenges and issues to TA director/CRD/CQM and or CTT (as appropriate).
  • Responsible for collaborating with functional outsourcing vendors, investigators, and other external partners in assigned studies.
  • Acting as country POC for programmatically outsourced trials for assigned protocols.
  • Serving local business needs as applicable in country (If delegated can sign contracts and manage budgets).
  • Collaborating internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies.
  • Building business relationships and representing the company with investigators.
  • Sharing protocol-specific information and best practices across countries\clusters.

Skills And Requirements

  • Knowledge in Project/Site Management.
  • Previous CRA/monitoring experience.
  • Requires strong understanding of local regulatory environment.
  • Strong scientific and clinical research knowledge is required.
  • Strong understanding of clinical trial planning, management, and metrics is essential.
  • The ability to focus on multiple deliverables and protocols simultaneously.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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