Description:
A global Pharmaceutical company is looking to hire a Lead Clinical Data Manager on a permanent basis. Working remotely, with a requirement to be onsite 1 day per quarter, my client can offer a collaborative and supportive working environment.
The successful candidate will support day-to-day operations in support of our client's drug portfolio across global studies and in collaboration with global teams.
Main Responsibilities:
- Act as a data management lead for external data processing in cross-functional clinical study team meetings
- Provide in-depth knowledge and consultation to the clinical study teams.
- Be responsible for study level data management activities of moderate to high complexity within a drug development program
- Perform external clinical data processing and reconciliation activities and may oversee CRO personnel performing the external clinical data processing and reconciliation activities as necessary.
- Ensure that studies within the program are executed within the agreed timelines and according to the agreed global standards and processes.
- Defining specifications for reconciliation checks and exception listings.
- Receiving production data transfers, reviews the discrepancy output of reconciliation checks and exception listings.
- Work with Data Management, Study Management, Bioanalysis and/or Stats/Stats Programming and/or the external data providers to resolve data discrepancies.
- Working with data standards subject matter experts to ensure data transfer structures and test codes comply with standard data models.
- Assessing complex data or procedural issues, chooses among alternatives, and facilitates resolution.
- Assisting and providing study level support to study teams and other team members.
Candidate Requirements:
- Educated to degree level or equivalent in a biological science, health-related or computer science field.
- Demonstrated experience in managing the creation of external data transfer specifications; leading study level UAT and QC of external data transfers; performing reconciliation data checks on external data.
- In-depth knowledge of drug development strategy, clinical trial, and data management processes.
- Experience with eClinical Solutions elluminate is a plus.