Senior CDM Lead — Late-Phase Trials (Remote)

Fortrea; Portugal; Híbrido; EUR 60 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Pension contributions

Health insurance

Remote working allowances

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Leadership

EDC experience

RAVE experience

Data management

Communication skills

Formação académica

Life science degree

Ferramentas

RAVE

EDC systems

Descrição da oferta de emprego

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.