Associate Director Clinical Data Manager (all genders)

Merck KGaA Darmstadt Germany

Associate Director Clinical Data Manager (all genders)

Stellenbeschreibung

Merck KGaA, Darmstadt, Germany

Associate Director Clinical Data Manager (all genders)

vor 3 Wochen26.9.2024
Darmstadt

Associate Director Clinical Data Manager (all genders)

Job Id 277689 Darmstadt, Hessen, Germany Job Type full-time, part-time possible

JOB DESCRIPTION

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:
    • Demonstrate good understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned studies in an assigned program/indication e.g. ensuring consistency across data quality plans
    • 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 non-study related initiatives e.g. process improvements, in addition to study assignments
  • Strong project management, analytical, communication, collaboration, and problem-solving 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 end-to-end 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: 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!

Apply now and become a part of our diverse team!

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WHAT WE OFFER

Money makes the world go round. But at Merck there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic.

Financial & Protection
These core benefits help to provide long-term financial stability for you and your family.
Health and Wellbeing
This pillar is important to us. Therefore, our health benefits are designed to support employees physical and mental wellbeing, e.g. health checkups or medical insurance.
Family
From our Fertility Benefit, to helping support your family life through all its different stages.
Time Away
Time to recharge and specific Leaves to support life events and choices
Life-style
Such as flexible working, gyms, car benefits, shopping discounts.

OuR RECRUITING PROCESS

Depending on the position (level, functional area, country) the process can vary slightly.
You apply

Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.

We screen
We review your application and if we determine that you are a good fit we will move you to the selection process.
We assess
You are interviewed by phone, via video and/or face to face.
Mutual agreement
Ideally you are the perfect match for us! We hope you consider us as your new employer.
Work your magic!
To guarantee you a smooth start our onboarding preparation begins.
Didn't find the right job just yet?

No problem at all! We’re always looking to meet new talent and stay in contact with you beyond an application. Join our Talent Zone to stay connected, learn more about our company, career opportunities and events. We’d love to hear from you.