Associate Director Clinical Services

☞ Abbott Laboratories

看过: 101

更新日: 06-05-2024

位置: Mumbai Maharashtra

类别: 咨询/客户服务 保健/医疗 药剂师/药剂师代表 服务/清洁工/女仆 PG / PB /接待处 事件

行业: Healthcare

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工作内容

Primary Job Function

The Associate Director Clinical Services provides leadership to the Clinical Services team within the Clinical Program Management function. Clinical Services function supports the efficient and compliant execution of Clinical Research activities by providing resources and capabilities in the area of: clinical systems and tools, budget oversight, performance and compliance management, external provider management and clinical study administration.

Core Job Responsibilities

  • Act as business owner of systems and tools used by the Clinical Development and Clinical Program Management functions, including but not limited to the Clinical Trial Management System
  • Stay up to date with technological evolutions in the area of Clinical Operations and evaluates the need for implementation of additional innovative technological capabilities.
  • Contributes to the development and implementation of the I&D IT roadmap. Leads the business implementation of newly selected technological capabilities
  • Leads collection, processing and reporting of system generated data and metrics to support the Clinical Program Management function in clinical study budget oversight, capacity planning, decision making on sourcing strategies for Clinical Research activities, performance evaluation.
  • Provides oversight to the management of external vendor engaged by the Clinical Program Management function
  • Provides clinical study administration services to the clinical study teams (eg. records management, archiving, public disclosure, …)

Supervisory /Management Responsibilities

  • Direct Reports: Senior Manager Clinical Resources, Senior Project Specialist (s), Data Analyst Clinical Services, Assistant Clinical Program management

Position Accountability / Scope:

  • Internal stakeholders Clinical Development and Medical Affairs team, Quality Assurance, Pharmacovigilance, Regulatory Affairs, Office of Ethics and Compliance, global, regional and local
  • External stakeholders business partners (contractors, consultants, vendors)

Minimum Education

  • Bachelor / Master of Science in a field related to life sciences or equivalent by experience

Experience:

  • At least 15 year experience in Clinical Operations in a CRO or pharmaceutical company
  • At least 3 years experience in the management and implementation clinical systems (Clinical Trial Management System, eTMF, eDC, IVRS, eSDV, remote monitoring)
  • Strong analytical skills
  • Experience with developing budget and resources assumptions for clinical studies
  • Experience with the management of external vendors
  • Experience with working in a Global fast paced environment
  • Demonstrated ability to influence cross functional teams acceptable
  • Proven Project Management skills
  • Expert in MS office applications especially Excel and PowerPoint
  • Fluent in English
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最后期限: 20-06-2024

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