Description
We are seeking a Data Management Lead to oversee data management activities for clinical trials. The successful candidate will be responsible for leading studies, developing project documentation, and ensuring data quality.
Job Summary: As a Data Management Lead, you will be responsible for providing data management leadership on studies and taking responsibility for the development of project documentation, system set-up, data entry, and data validation procedures and processes. You will work directly with sponsors to understand their requirements and lead implementation of those requirements.
Key Responsibilities:
- Lead studies, including healthy volunteer and patient populations, multi-site, client management required or reduced timelines
- Be accountable for all data management deliverables, providing instruction to data management study teams and reviewing their output to ensure high quality
- Ensure that all allocated projects are carried out in strict accordance with relevant protocols, global harmonized SOPs, and GCPs
- Work with project managers to build timelines and communicate with leads in different disciplines and the full project team
- Provide data management project team leadership and accountability
- Maintain awareness of other biometrics functional group deliverables to support risk and mitigation strategies
- Develop and maintain client relationships and review client satisfaction surveys
- Track scope changes and work with project managers to ensure sponsor approval is received
- Provide leadership, mentorship, and coaching in data management-related clinical trial processes to internal study teams
- Support data management managers on performance evaluations of team members and provide constructive feedback
- Stay up-to-date with industry-wide technology and feasibility for process improvement
- Maintain accurate records of all work undertaken
- Perform reconciliation of clinical databases against safety data, laboratory data, or other third-party data
- Represent data management and biometrics in new business opportunities
- Attend and action client or internal audits and resolve issues within an appropriate timeframe
Requirements:
- University/college degree
- 6-8 years of data management experience with a minimum of 1 year of direct sponsor management
- Experience in handling customer concerns and managing scope of work and budgets
- Knowledge of clinical trial process, data management, clinical operations, biometrics, and system applications
- Time management skills and ability to adhere to project productivity metrics and timelines
- Ability to work in a team environment and collaborate with peers
- Good organisational ability, communication, and interpersonal skills
- Knowledge of medical terminology
- Fluent in English, both written and verbal