Lead Clinical Data Manager

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. This role is open to candidates based in the UK, Ireland and the Netherlands.

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.

For additional information and a confidential discussion, please apply now with an updated CV.