Accountable for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
Performs all required management responsibilities including but not limited to: implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization.
Communicate study status, cost and issues to ensure timely decision-making by senior management
Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
Oversee the creation of site materials including training, manuals and support documentation
Perform periodic review of clinical data, quality metrics and study deviations
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
Provides input into the development of study protocols and CRFs to ensure studies are designed and planned to be achievable

Requirements

Bachelor's degree in related field; minimum of 6 years of clinical operations experience in industry or CRO setting
3+ years of management experience
Exceptional communication and interpersonal skills
Excellent written and oral communication skills
Knowledge of national / regional clinical trial regulations and industry standards regarding interactions with healthcare professionals essential
Wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical operationsstudy protocolsCRFsclinical data reviewquality metricsbudget managementtimeline developmentissue managementcontingency planning

Soft Skills

communication skillsinterpersonal skillsmanagement skillsproblem-solvingemployee productivityteam collaborationdecision-making

Certifications

Bachelor's degree