Senior Clinical Data Manager - FSO

Fortrea; Portugal; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Pension contributions

Health insurance

Remote working allowances

Job summary

Fortrea is seeking a Senior Clinical Data Manager (remote or hybrid) to lead data management activities on late-phase studies within our Late Phase team. You will develop global data management and quality plans to ensure timely, accurate data delivery and act as the technical leader across start-up to completion.

The role requires EDC expertise (RAVE preferred) and strong collaboration with cross-functional teams to manage data models, CRFs, and data review processes.

Qualifications

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution.
• Lead experience across a mix of therapeutic areas especially 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.

Responsibilities

• 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.
• 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.
• Interact and collaborate with other project and specialty team members to support the set-up, maintenance, and closure of the data management aspects of the project to ensure data handling and quality.
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

Skills

Leadership

EDC experience

RAVE experience

Data management

Communication skills

Education

Life science degree

Tools

RAVE

EDC systems

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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