Senior Clinical Research Manager (REMOTE)

Siemens Healthineers

1d•Remote

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The Senior Manager, Clinical Research is responsible for the planning, execution and interpretation of clinical trials and registries at Varian, as well as managing several Clinical Trial Managers. This person will ensure adherence with internal procedures and external clinical trial requirements, as well as ensuring projects are appropriately resourced and employees are trained and meeting project objectives.

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

Responsibilities

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