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You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
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 we are Looking for:
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
3 to 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.
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
