Senior Clinical Data Manager - FSO

Fortrea; United States; Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Remote or hybrid work

Pension contributions

Health insurance

Remote working allowance

Job summary

Fortrea is seeking a Senior Clinical Data Manager to lead data management on late-phase (IIb-III) studies in a remote or hybrid setup. You will serve as the technical lead for CDM deliverables, develop global Data Management Plans, and collaborate with cross-functional teams to ensure timely, accurate data.

The role offers mentoring from senior leaders, flexible hours, and a permanent Fortrea contract. EDC/RAVE experience and strong communication are essential for success.

Qualifications

• University/college degree in life sciences or related field; certification considered.
• Experience leading data management in late-phase trials (IIb-III).
• Strong knowledge of CDM processes, QA, and data governance.
• Excellent written and spoken communication and presentation skills.

Responsibilities

• Serve as the technical leader on data management for start-up, maintenance, and close-out activities.
• Develop global Data Management Plans and QM Plans to ensure high-quality data.
• Identify and implement solutions to data management issues with proactive metrics.
• Coordinate status updates, cycle time, and productivity metrics with clients and team.
• Collaborate with cross-functional teams (clinical, programming, statistics) on data model and CRF design.
• Guide data review conventions and validations, and oversee listings and discrepancy management.
• Support project risk management, resource planning, and staff performance reviews.

Skills

Leadership

Data management

CDM

Communication skills

Project management

Education

Life sciences degree or related

Allied health certification

Tools

RAVE

EDC systems

Clinical data management tools

Job description

Senior Clinical Data Manager (remote or hybrid) – Full Service

Do 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 us

• Office based or home based in the listed countries in EMEA

• Rewarding and meaningful work in an established, diverse, highly profitable and respected global company

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

• A genuine work life balance

• Flexibility in working hours

• A thorough onboarding with support from your personal mentor

• A permanent employment contract with Fortrea

In this opportunity, you wil

• Serve 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 profile

• University/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:

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