Associate Clinical Lead (BB-1DB94)
Encontrado en: Jooble AR
Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Associate Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.
• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
• May work as the sole Clinical Lead on projects with 1-2 service lines and single/few countries or alongside more senior Clinical Leads to deliver large, global trials.;
• May attend site visits as applicable in support of project delivery.
• Bachelor's Degree Bachelor's Degree in health care or other scientific discipline required
• Requires 3 years clinical research/monitoring experience or equivalent combination of education, training and experience.;
• Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;
• Requires broad protocol knowledge and therapeutic knowledge.;
• Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
• Requires basic understanding of project finances.;
• Communication - Strong written and verbal communication skills including good command of English language.
Therapeutical Area: CNS.
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