Senior Clinical Data Manager

hace 5 meses

Barcelona, España Merck KGaA A tiempo completo

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team.
As a Senior Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization. You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting.

**Your role**:Accountable for all Clinical Data Management related deliverables in assigned global (Phase I-IIIb) trials of varying complexity
Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding)
Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activities
Represent Clinical Data Management within the Core Trial Team and serve as a key point of contact for the Data Management related tasks in a trial/project/program
Ensure quality of clinical database/deliverables (incl. eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
Provide project management for all clinical data management related deliverables e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc
Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)
Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.

**Who you are**:

- Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, or a related field
- Minimum of 8 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry
- Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement
- Demonstrated ability to lead and oversee end-to-end data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organization
- Strong project management, communication, collaboration, and problem-solving skills
- Ability to work proactively and independently on assigned tasks or projects of varying complexity
- Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management
- Experience with clinical trial data standards, such as CDISC, is preferred English fluent

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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