Manager, Clinical Data Sciences - Remote

Data Management United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Manager, Clinical Data Sciences to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

As a Manager, Clinical Data Sciences, you will have the opportunity to serve as line manager to a team of data management experts, supporting recruitment, onboarding, training, mentoring, and resourcing within the department. You will participate in business development opportunities and study budgeting and contribute to process improvement and cross-functional initiatives. When designated you will act as the Clinical Data Sciences point of contact for a client or portfolio, ensuring that all captured data follow the rules outlined by a study protocol and operational plans. You will be responsible for quality oversight of documentation required for study execution, as developed by direct reports and supporting staff. You will have the opportunity to impact change, support development of your direct reports, interact cross-functionally, and grow with us at Premier Research.

What you’ll be doing:

  • Manage Lead Data Scientists with respect to data management skill development, training, career development, issue resolution, performance management, billing practices, and adherence to Premier Research SOPs/Guidelines and GCP standards
  • Lead, mentor and train junior staff in an aspirational and empowering working environment
  • Onboard, train, and evaluate new employees to facilitate integration into the department and to reach target utilization in a timely manner; participate in resource allocation and utilization discussions with the management team
  • Coordinate and act as point of contact for Clinical Data Sciences for designated client portfolios, including governance, standards, quality, and operational delivery
  • Review and contribute to the development/update of department SOPs and Working Guidelines
  • Lead task force groups that impact Clinical Data Sciences
  • Participate in project costing estimates and proposal review in the business development/change order process
  • Deliver proposal defense and capabilities presentations

You’ll need this to be considered:

  • Educated to Bachelor’s degree or above, preferably in a life science, along with 6-8 years of data management experience and at least 2 years of people management experience
  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures; understanding and experience with up to date MS Windows Operating Systems and applications and at least two clinical data management system (e.g., Medidata Rave, Calyx DataLabs EDC, Medrio, Oracle Clinical One, etc.)
  • Familiar with all phases of a study, e.g., study startup/database setup, maintenance, and lock
  • Knowledge of data mining and the application of data standards desirable
  • Knowledge of statistical principles and analysis considerations
  • Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
  • Excellent team player; collaborative and able to build an effective team
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines in a fast-paced environment
  • Accountable, dependable and committed to quality
  • Customer service focused approach (both internally and externally)
#LI-AB1