Senior Clinical Data Manager – FSO

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as the technical leader for all data management elements in projects, encompassing initiation, maintenance, and completion tasks.

• Create comprehensive Global Data Management Plans and Quality Management Plans.

• Recognize and implement solutions for project data management challenges, including proactive prevention strategies informed by metrics and forecasts.

• Function as a liaison between the project and the client, overseeing and reporting on project-specific data management status, cycle time, and productivity metrics.

• Organize and engage in the development of the clinical data model and/or database design, as well as annotate CRFs/eCRFs.

• Evaluate data acquisition conventions, data review guidelines, and diagnostic specifications.

• Coordinate the development and testing of data management system edit/data validation checks, diagnostics, and special listings/procedures.

• Collaborate with clinical, programming, statistics, CDM technical support, drug safety, and other project and specialty teams.

• Lead proactive planning and risk management, including the escalation of issues and resource management.

• Supervise the technical performance of data review project staff and ensure the delivery of quality data on time and within budget.

• Assist in setting goals and conducting performance review assessments for data review project staff.

• Maintain technical data management skills through participation in internal and external training seminars.

• Ensure that project staff are trained and comply with project-specific and globally standardized data management processes.

• Identify opportunities for process and efficiency enhancements and implement necessary solutions.

• Support the achievement of project revenue and operating margin goals for data management activities.

• Contribute to business development by providing data management time and cost estimates, as well as presentations to potential clients.

⛳️ Requirements

• A university or college degree (preferably in life sciences, pharmacy, or a related field), or certification in a relevant allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).

• Additional pertinent work experience may be accepted in place of formal qualifications.

• Leadership experience across a variety of therapeutic areas, particularly in Late Phase (IIb-III) trials.

• Experience with Electronic Data Capture (EDC), particularly RAVE, with familiarity with other EDC systems being advantageous.

• Exceptional oral and written communication skills, along with strong presentation capabilities.

• Comprehensive understanding of the clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications that support operations.

• Familiarity with the relationship and regulatory obligations of the Contract Research Organization (CRO) industry in relation to pharmaceutical/biotechnological companies.

• Ability to lead project teams towards project strategies and accomplish department goals, objectives, and initiatives.

• Willingness to motivate team members to pursue solutions.

🏝️ Benefits

• Highly competitive compensation packages, which include various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, etc.

• A genuine commitment to work-life balance.

• Flexible working hours.

• Comprehensive onboarding with support from a personal mentor.

• A permanent employment contract with Fortrea.