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:

• Interacts with internal and external project team members (including external data source vendors) as appropriate. Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes 

• Ability to facilitate clinical database development to execute the collection, receipt, reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and execution of User Acceptance Testing, and coordination, planning and development for external data sources. 

• Participates in early study team planning of data risk assessment and continuous evaluation of risks throughout the course of a study. Ability to offer insight or mitigate risks of data loss.  

• Lead communications with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. Ensure training of study specific protocol requirements as appropriate. 

• Ability to create, maintain, execute and store data related documentation as outlined in department operation procedures and as required by study 

• Responsible for functional area eTMF filing and quality control activities or equivalent as per study 

• Responsible for oversight of study budget applicable to functional area. Ability to identify and communicate potential out of scope activities to project team as appropriate. Work with study team to provide needed information for re-scoping when applicable. 

• Responsible for the generation, review and reporting of study metrics and financials as needed 

• Responsible to execute all tasks as aligned with SOPs, department guidelines and data standards.

What We Are Searching For:

• Bachelor’s Degree preferably in a Life Science required

• 4-6 years mastery in Data Management or relevant Industry experience, with at least 0-2 years’ experience Leading studies

• Experience working within at least two clinical data management systems and in-depth knowledge of at least one, preferably Medidata Rave or DataLabs EDC

• Familiar with all phases of a study, e.g., study startup/database set-up, maintenance, and lock
• 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)
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously