Lead Data Manager - Home-Based
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Lead Data Manager to join our 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!
The Lead Data Manager serves as a member of the project team with the lead responsibility for reviewing CRFs, data listings, and databases to ensure that all captured data follow the rules outlined by the protocol and data management plan. They are also responsible for the preparation of data management plans(DMP), data entry guidelines, data management reports and other documents required for preparing and completing databases.
You'll be Accountable for:
- Responsible for independently leading end-to-end data management activities, including but not limited to, accurate and timely database design, database setup (including CRF and Non-CRF collection tools), data cleaning, and data management documentation
- Prepares the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents as required
- Participates in and coordinates study team review of CRFs for potential data collection, database structure, or data entry problems as well as to ensures all captured data follows the rules outlined by the protocol and data management plan
- Manages 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
- Participates in and manages the progress of data cleaning activities including the generation and resolution of queries and discrepancies
- Ensures 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
- Interacts with the Project Manager or designee on a continual basis throughout the course of the study, when applicable.
- Liaises with the sponsor as needed to discuss issues and provide data management updates
- Ensures the Trial Master File (TMF) is accurate and contemporary at all times throughout the lifecycle of the trial
- Mentors and trains Data Managers
- Performs additional duties as assigned
- Ability to perform overnight business travel, up to 10%
You'll Need This to be Considered:
- 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 to 7 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