Category

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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