Senior/Lead Data Manager - Oncology

Functional Services United States East Hartford, Connecticut Waltham, Massachusetts North Brunswick Township, New Jersey Philadelphia, Pennsylvania Morristown, New Jersey Baltimore, Maryland New York, New York Pittsburgh, Pennsylvania


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.

We’re looking for a talented and energetic Senior/Lead Data Manager with Oncology experience to join our Functional Services team!

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

What you’ll be doing:

  • Independently lead end-to-end data management activities, including, accurate and timely database design, database setup (including CRF and Non-CRF collection tools), data cleaning, and data management documentation
  • Prepare the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents
  • Participate in and coordinate study team review of CRFs for potential data collection, database structure or data entry problems to ensure all captured data follows the rules outlined by the protocol and data management plan
  • Manage the development of the data validation plan per the protocol and ensures user acceptance testing of CRFs and associated edit checks are completed in accordance with project timelines
  • Manage the progress of data cleaning activities including the generation and resolution of queries and discrepancies
  • Ensure the accurate and timely reconciliation of third party data with Clinical Data Management System (CDMS) data.
  • Tracks CRFs as they are processed through the Data Management department
  • Interact with the Project Manager or designee on a continual basis throughout the course of the study.
  • Liaise with the sponsor to discuss issues and provide data management updates
  • Ensure the Trial Master File (TMF) is accurate and contemporary at all times throughout the lifecycle of the trial
  • Mentor and train Data Managers
  • Ability to perform overnight business travel, up to 10%

You’ll need this to be considered:

  • Bachelor degree, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience along with 6+ years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (e.g. -Oracle RDC / Inform, Medidata Rave, DataLabs, etc.) with at least 2+ years of oversight experience;
  • Working experience in Oncology studies
  • 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 (e.g. 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
  • Must be able to travel to the Northeast occasionally