Senior Clinical Data Manager - FSO

Fortrea; Maidenhead; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Pension contributions

Private health insurance

Remote working allowances

Job summary

Fortrea is seeking a Senior Clinical Data Manager (remote or hybrid) to lead data management activities across late-phase studies. You will develop global data management and QM plans, manage project data metrics, and serve as the liaison with clients and internal teams to ensure high-quality, timely clinical data delivery.

The role requires extensive EDC experience (RAVE preferred) and strong communication. Fortrea emphasizes support from mentors and a collaborative work environment across EMEA.

Qualifications

• Bachelor's or higher in life sciences or related field.
• Proven experience leading data management on late-phase (IIb–III) trials.
• Strong knowledge of EDC systems, QA/QC, and data review.
• Excellent written and oral communication with stakeholders.

Responsibilities

• Serve as the technical lead for data management on assigned projects.
• Develop and maintain global Data Management and Quality Management Plans.
• Coordinate data management activities across startup, maintenance and closeout.
• Collaborate with cross-functional teams to ensure data quality and timely delivery.

Skills

Data management leadership

Late-phase trials

EDC systems

RAVE experience

Regulatory knowledge

Communication skills

Education

Life science degree

Tools

RAVE

Medidata

Job description

Senior Clinical Data Manager (remote or hybrid) – Full ServiceDo you have experience leading data management activities across late phase studies? Are you looking for a new challenge in an environment where you be closely supported by your Manager, peers and Senior Leaders in your team?Join our growing team and discover your extraordinary potential by working as a Senior Clinical Data Manager within our Late Phase team.What you can expect from usOffice based or home based in the listed countries in EMEARewarding and meaningful work in an established, diverse, highly profitable and respected global companyHighly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.A genuine work life balanceFlexibility in working hoursA thorough onboarding with support from your personal mentorA permanent employment contract with FortreaIn this opportunity, you wilServe as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.Develop global Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.Advanced planning and risk management for projects (issue escalation, resource management).Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.Assist with goal creation and performance review assessment for data review project staff.Maintain technical data management competencies via participation in internal and external training seminars.Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.Identify areas for process and efficiency improvement and implement solutions on assigned projects.Support achievement of project revenue and operating margin for data management activities to agreed targets.Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.Your profileUniversity/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).Additional relevant work experience will be considered in lieu of formal qualifications.Lead experience across a mix of therapeutic areas especially across Late Phase (IIb-III) trials.EDC experience – ideally you will have RAVE experience and experience across other EDCs would be advantageous.Excellent oral and written communication and presentation skills.In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com .Fortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement .If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: [e-mail] . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.Learn more about our EEO & Accommodations request here .