Study Data Manager

Reference Number: 896245-W
Type of placement: Contract, Contract
Location: CH, NW

Introduction:

To operate as the core representative for Clinical Data Management (CDM) on the study team and to be accountable for collection, review and management of data and ensure deliverables are met. 

Main Responsibilities:

  • Leads the Clinical Data Management study team and maintains oversight of all build, conduct and close activities for one or more studies, ensuring fit for purpose quality
  • Implements study conventions, processes, knowledge sharing and best practices on assigned study(s)
  • Effectively communicates study goals and status of work, including all requirements to Clinical Data Management study team and stakeholders
  • Shares knowledge using relevant forums and communication tools
  • Manages Clinical Data Management study deliverables, including timelines, risks and coordination of cross-functional tasks
  • Identifies and escalates study issues appropriately and addresses corrective action plans
  • Evaluates the impact of risks, and develops and implements mitigation plans at the study level
  • Provides coaching and mentoring on sub functional activities to peer Study Data Managers (SDMs) and associate Study Data Managers (aSDMs)
  • Provides timely feedback to individuals and to Clinical Data Management, and seeks ongoing feedback for personal development.
  • Fosters teamwork
  • Develops and maintains working relationships within and outside of Clinical Data Management at the study level
  • Contributes or leads sub functional or cross functional working groups and initiatives
  • Adapts to change, E.g. new tools, processes and technology
  • Maintains outsourcing relationships and oversight with partners and inputs to CRO selection participation & review of work orders & scope of work (SOW)
  • Provides vendor performance oversight on an ongoing basis

Qualifications and Experience:

  • BA/BS degree or equivalent and moderate industry-related experience
  • Moderate practical and theoretical expertise within his or her sub function
  • In-depth understanding of the business of his or her sub function and the wider Clinical Data Management
  • Leadership experience
  • Sound understanding of clinical development
  • Experience with RAVE
  • Oncology experience is an asset
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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