Clinical Data Manager

Biostats & Data Management & Medical Multiple, United States


Description

Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinical Operations and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the time it takes to lock a database by up to 95% for Vaccine studies, we don’t want to stop here, we want to recognize process inefficiencies in clinical operations and data management and disrupt them. We are firm believers in re-imagining data management and analytics, what we have done so far is just scratching the surface, a lot more has to be done with you on our team leading some of these transformational initiatives.

 

Product Owner acts as Data Management SME and serves as the main point of contact for customers to implement clinical solutions. You will work closely with Clinical trial sponsors, CROs at the executive and study team level to deliver Saama solutions to our customers.

 Responsibilities

  • Drive customer implementations to successful launch by providing data management inputs wherever necessary.
  • Work with implementation resources, product, and engineering teams onshore and offshore to deliver innovative solutions to customers.
  • Consult with business leaders to develop and understand the complex and diverse data management needs required for the project.
  • Understand the role of the project in the clinical landscape and determine how changing business needs will affect the project.
  • Collaborate with the customer and internal resources to understand usage and adoption trends and impact increased application use.
  • Partner with Business development and customer success managers to implement solutions, estimate effort and help set customer expectations.
  • Partner with Product Management to help align real-world customer feedback with the product roadmap.
  • Perform the industry research to identify clinical development needs.

 

Requirements

  • Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience.
  • 10-15 years industry experience working with EDC, IRT systems and integrations, third party data handling and other clinical systems implementation.
  • Experience in Clean patient tracker, data review, missing pages, data quality checks, 3rd party data reconciliation and use of business intelligence tools like Cognos, Oracle, BI, Tableau, Spotfire, QlikView, Informatica.
  • Familiar with clinical trial data and related workflows.
  • Excellent understanding of common industry standard business practices related to clinical trials (study set up, study conduct, clinical operations process, data management review and reporting).
  • Excellent at translating customer business requirements into enterprise solutions.
  • Proven track record of driving customer success and operating at the executive and department levels within complex customer environments.

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