Principal Lead Clinical Data Manager

Full time – Remote anywhere in the US or hybrid if local to Durham, NC

The Principal (Lead) Clinical Data Manager is a problem solver. This is someone who is curious and an out-of-the box thinker. Our data management team never cut corners. Excellence is not just a word, it’s the measure for what this team does. At Aperio you won’t get moved from study to study, picking up pieces or cleaning up a mess. You will collaborate and build relationships with your sponsors. You are a leader.

What you’ll be doing:

  • You will manage a data management project, what does that include:
    • Own your own studies and project deliverables
    • Identify roadblocks, overcome hurdles and provide solutions
    • Review budgets
  • You will manage clinical data and query review
  • Create the Data Review Plan
  • Issue queries and review query responses
  • Reconciliation (LAB, SAE, ECG, and other vendors)
  • You will oversee system development and modifications:
    • Draft the CRF design, edit check specification and DM listings
    • Manage all database build and modifications
  • You will create and maintain documentation for assigned projects
    • Data Management Plan, CRF Completion guidelines, Data Entry guidelines, Edit specifications, Reconciliation guidelines and Report specifications
    • Database release documentation
    • Project Specific SOPs/WPs
  • Performs other duties – what do you want to learn?

What we are looking for in a candidate:

  • BA/BS degree required with 10 years of experience in clinical research (8 years in data management); OR
  • 12 years of experience in clinical research (10 years in data management) may be accepted in lieu of a degree
  • Experience with Microsoft Office suite and strong working knowledge of electronic data capture systems (Medidata Rave preferred)
  • Knowledgeable in Clinical Research, ICH GCP and medical terminology
  • Ability to travel occasionally

 

Aperio Clinical Outcomes provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.