Clinical Operations Lead
Global Leader in Oncology Clinical Research
Top 3 US CRO
- Fully integrated end-to-end clinical and commercial solution organization.
- Purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace.
- Clinical and commercial sharing expertise and data and insights to meet the needs of emerging and major global biopharmaceutical companies
- 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.
- May participates in business development proposals, defense meetings and proposal development.
- As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables.
- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality.
- Reviews 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. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
- 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
- Must demonstrate good computer skills
- Excellent communication, presentation and interpersonal skills.
- Ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%
- Develop your career at an industry leading clinical research organisation
- Contribute to global clinical trials
- Gain additional experience by working with oncology and neuroscience experts