Clinical Operations Lead

About the Company

This opportunity will be within a Global CRO reporting directly to a single sponsor. This market leading pharmaceutical company is expanding their team to take on a variety of new studies and indications into the coming year with a specific focus on oncology. Clinical Operations Leads are needed on a permanent, full time basis.

Job responsibilities

• Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.

• May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP).

• Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.

• Ensures alignment of clinical activities to budget, including identification of out-of-scope activities.

• May participate in business development proposals, defence meetings and proposal development.

• Adheres to scope and routinely reviews Clinical Trial Management System (CTMS) and relevant files and documents.

• Evaluations the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct.

• Understands the monitoring approach required for the study and where required participates in the development of the study risk assessment plan. Is responsible for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

• Work in Partnership with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for Clinical Scope.

Skills and qualifications

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Demonstrated ability to lead and align teams in the achievement of project milestones, demonstrated capability of working in an international environment
• Knowledge of basic clinical project financial principles
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Happy to consider clinical research professionals from non-industry
• Great step up for a SCRA with lead capabilities or a Clinical Study Manager or Coordinator
• Excellent communication, presentation and interpersonal skills.
• Excellent problem-solving skills
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues

Click apply or contact Maddy Rhodes-Laird at MRhodes-laird@hpgconnect.com