Hybrid Senior Data Management Lead - Clinical Trials

Eisai Europe Limited; United Kingdom; Hybrid; GBP 85,000 - 120,000; Full time

Benefits offered by this job

Hybrid working

Car/Car Allowance

Electric charging points

Discretionary Bonus

Free onsite parking

Subsidised onsite restaurant

Learning and development opportunities

Well-being & mental health awareness

Multi-faith prayer room

Job summary

Eisai Europe Limited is seeking a Senior Manager, Data Management to lead data collection and processing across studies, ensuring high-quality data and regulatory compliance. The role demands cross-functional collaboration, vendor oversight, and team leadership to align DB builds with Eisai standards.

MDP oversight, protocol input, SOP maintenance and CRO governance are key facets of this position, with a focus on timely data delivery and continuous process improvement.

Qualifications

• Bachelor’s degree in sciences or related field with demonstrable experience of Clinical Data Management in pharma/biotech industry OR a combination of equivalent education and experience.
• Experience in Project Management (i.e. defining plans and milestones, coordinating with cross functional teams and driving accountabilities).
• Experience working with clinical trials and the drug development process; understanding of Data Management strategy.
• Experience leading Data Management activities in clinical trials.
• Proficient use of Data Management systems with strong knowledge of Data Management processes, tools, methodologies and documentation.
• Strong experience and knowledge of clinical research, GCP, regulatory requirements and good Data Management practices.
• Some experience with line management; mentoring team members (external/contract staff) on Clinical Data Management activities and procedures preferred.
• Proven performance in earlier role.

Responsibilities

• Develop and review standard Case Report Forms (eCRFs), Data Management Plans, Validation Specifications and Data Transfer Specifications.
• Provide Data Management inputs during study protocol development; contribute to the enhancement of a clinical library.
• Participate in the development/maintenance of Data Management SOPs, Standard Working Practices, and other Data Management related process documents as needed.
• As appropriate, contribute to the selection, oversight of CRO performance related to Data Management activities; act as the sponsor representative for Data Management outsourced activities.
• Represent the Data Management function in study teams meetings.
• Ensure timely delivery of quality data in accordance with Eisai's SOP, industry standards, and regulatory guidelines.
• Work closely with cross functional teams to ensure delivery of quality data; represent Data Management team in study team meetings and provide Data Management questions to internal and external team members.
• Execute managerial duties to direct reports and/or provide guidance to members.

Skills

Clinical Data Management

Project Management

Data Management systems

GCP knowledge

Regulatory requirements

Mentoring/Line management

CRO oversight

Education

Bachelor's degree in sciences

Tools

Data Management systems

Job description

Eisai Europe Limited is seeking a Senior Manager, Data Management to lead data collection and processing across studies, ensuring high-quality data and regulatory compliance. The role demands cross-functional collaboration, vendor oversight, and team leadership to align DB builds with Eisai standards.

MDP oversight, protocol input, SOP maintenance and CRO governance are key facets of this position, with a focus on timely data delivery and continuous process improvement.