Senior Data Management Lead - Clinical Trials

Eisai EMEA; Hatfield; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working

Car/Car Allowance

EV 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

You will join Eisai as Senior Manager, Data Management to lead data collection and processing for clinical studies from start-up through completion. In a highly matrixed environment, you will manage outsourced vendor activities and internal resources, directing teams and ensuring data quality in line with Eisai standards.

You may also act as compound lead for select projects to ensure consistent DB builds across protocols, driving data integrity and regulatory compliance across studies.

Qualifications

• Bachelor’s degree in sciences or related field with demonstratable 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

Project Management

Clinical Data Management

Leadership

Vendor Management

GCP knowledge

Education

Bachelor’s degree in sciences or related field

Tools

Data Management systems

Job description

You will join Eisai as Senior Manager, Data Management to lead data collection and processing for clinical studies from start-up through completion. In a highly matrixed environment, you will manage outsourced vendor activities and internal resources, directing teams and ensuring data quality in line with Eisai standards.

You may also act as compound lead for select projects to ensure consistent DB builds across protocols, driving data integrity and regulatory compliance across studies.