AD/Director, CDS, Risk-Based Data Strategy - Remote

Clinical OperationsRemote, United States


Description

Position at Premier Research

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today. 

We’re looking for a Director, Clinical Data Sciences, Risk-Based Data Strategy to join our Clinical Data Sciences team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success

What you'll be doing:

  • Drive successful execution of adaptive quality management project in line with short, medium and long-term strategies and strategic plan for study monitoring to support the organization in becoming the industry leader in adaptive monitoring
  • Track and review progress of all initiatives and projects and ensure they support strategic goals
  • Collaborate with key stake-holders to develop and deploy an adaptive monitoring strategy and quality management strategy that is in line with guidance from ICH-E6 (R2); responsible for developing the processes, implementing the technology and building the expertise to enable holistic oversight of clinical site performance to proactively direct the monitoring effort.
  • Drive a risk-based approach to study planning and design and build out procedures to manage clinical and operational data based on protocol/analysis level risk throughout trial execution
  • Lead deployment of data-driven innovations that result in step-change in monitoring processes/data cleaning practices with significant enhancements to efficiency and productivity

What We're Searching For:

  • Minimum of a Bachelor’s degree (BS, BA, or RN equivalent) or its international equivalent required; clinical, science or health related field from an accredited institution or a licensed healthcare professional (advanced academic degree is preferred). 
  • Minimum of ten (10) years clinical research experience with at least three (3) in a CRO environment and minimum three to five (3-5) years supervisory / management experience including oversight of large groups (>= fifty (50) people)
  • Ability to drive projects to a successful completion both as a project leader and within a leadership role
  • Is customer service focused in approach to work both internally and externally
  • Knowledge of FDA Guidance Documents / EU Directives / NA Directives/ISO14155 regulations, drug / device development, and clinical monitoring procedures
Why Choose Premier Research:
  • Premier Research is more than a company –it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
  • Our cultural anchors –Caring & Empathy, Empowerment, Aspiration, One Team –mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

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