• Contract
  • Remote

SimulStat

Remote, 5-month contract, possible renewal based on business needs

The Data Management Lead ll provides leadership and expertise in all aspects of Data Management.

Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management single point of contact to ensure that the contracted Data Management deliverables are being met specifically in terms of timeliness, financial management and quality. The Data Management Lead ll works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services

Skills:

  • Strong ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively
  • Strong negotiation skills and ability to influence in order to achieve mutually beneficial results
  • Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach
  • Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
  • A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments
  • Proficient presentation skills
  • Customer focus to interact professionally and respectfully within internal and all external colleagues to build rapport and trust
  • Commitment to first time quality, including a methodical and accurate approach to work activities
  • Time management and prioritization skills, in order to meet objectives and timelines
  • Proven problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses
  • Ownership and accountability for Key Accountabilities in Job Description
  • Ability to travel as required
  • Written and oral fluency in English

Knowledge and Experience:

  • Strong experience in clinical research industry
  • Proven record of leading project and program teams
  • Good understanding and application of project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
  • Good understanding of Clinical Study Team roles outside of Data Management
  • Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and SOPs and study specific procedures
  • Awareness of SDTM/CDISC/CDASH standards
  • Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data
  • Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products

Education:

Bachelor’s degree and/or other qualifications in a science or clinical related industry.

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