Associate Director Clinical Data Manager - Barcelona, España - Merck KGaA

Merck KGaA

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

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 an Associate Director 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 (CDM) related deliverables in assigned global (Phase I-IIIb) trials or programs of varying complexity
Provide CDM leadership for assigned trial(s)/program(s), take global accountability and serve as the CDM representative at the study/program level
Demonstrate project management and operational expertise in the strategic planning and delivery of CDM deliverables at study/program level, e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc
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
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)
Act as primary point of contact within CDM for any HA submission related activities (e.g. preparation of briefing books, attending HA meetings as requested)
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.
Lead process improvement initiatives and drive innovation in the field of Clinical Data Management

Additionally, if assigned to a program:
Utilise understanding of CDASH and SDTM, or other recognised industry standards, to ensure consistency of implementation across studies in assigned program/indication
May act as a mentor for CDM colleagues within/beyond assigned program
Demonstrate willingness to take on and lead any program level activity in support of study delivery

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 10 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
Proficient in contributing to nonstudy related initiatives e.g. process improvements, in addition to study assignments
Strong project management, analytical, communication, collaboration, and problemsolving skills
Ability to work proactively and independently on assigned tasks or projects of varying complexity; prioritising and managing multiple activities simultaneously
Demonstrated ability to lead and oversee endtoend data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organization
Familiar with autonomously providing reports to senior management, including updates on financials, forecasts and timelines
Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management
Experience in Risk Based Data Monitoring/Management, and with clinical trial data standards, such as CDISC, is preferred English fluent

What we offer:
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