Senior Clinical Data Manager - Remote

Functional Services 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 Senior Clinical Data Manager 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.

What you'll be doing:
  • Responsible for all Data Management (DM) activities including the application of data standards, data management plan, risk indicator, and third party data
  • Ensures and/or affirms study start up documentation aligns with Data Standards and Standard Operating Procedures (SOPs)
  • Develops and/or ensures quality in the database design including both CRF and non-CRF data collection modules, edit checks and data review listing, and other activities up to database release
  • May be responsible for risk-based monitoring setup
  • Ensures final database DM documents are complete and all data issues have been tracked, reviewed, reconciled, and resolved per SOPs
  • Proactively drives quality of deliverables as well as ensures timelines and milestones are met in collaboration with cross functional teams
  • Escalates issues from DM teams as needed
  • Works directly with the cross functional team to support day to day interactions for DM activities
  • Ensures consistency and quality of the data management activities
  • Trains and follows Standard Operating Procedures as applicable
  • Performs other duties as assigned
What you'll need:

  • Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience
  • 5 years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions.
  • Oncology experience preferred
  • Demonstrates excellent English verbal and written communication skills
  • Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)
  • Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
  • Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
  • Project management experience preferred