Associate Director Clinical Data Manager (all genders)

Merck Healthcare; Warszawa; On-site; PLN 320,000 - 520,000; Full time

Benefits offered by this job

Health and well-being programs

Career development opportunities

Flexible work options

Job summary

Merck Healthcare in Warsaw leads a complex Clinical Data Management program, overseeing CDM activities across multiple global trials from Phase I to IIIb. The role requires steering data quality, timelines, and cross-functional collaboration in a dynamic matrix structure.

You will manage CROs and vendors, define risk-based data strategies, and ensure compliance with industry standards (CDISC). Leadership across study and program levels is essential, possibly mentoring peers and contributing to

Qualifications

• Bachelor's or Master's degree in Life Sciences, Data Management or a related field.
• Minimum 10 years of experience in clinical data management in pharma/biotech/healthcare.
• Extensive leadership of CDM activities in complex oncology programs and trials.
• Strong project management, communication, and problem-solving skills.

Responsibilities

• Lead end-to-end clinical data management activities across global trials and programs.
• Manage CRO/vendor selection, performance, budgets and timelines.
• Define risk-based data collection, cleaning, coding and QA strategies for eCRF and external data.
• Mentor colleagues and drive process improvements and SOP development.
• Support CDM aspects of regulatory submissions and HA interactions.

Skills

CDM leadership

Oncology trials

Project management

Regulatory compliance

Stakeholder engagement

Data quality

Matrix leadership

Education

Bachelor's or Master's degree in Life Sciences, Data Management, or related field

Tools

CDISC

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.

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 (all genders), 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.

This role requires to be on-site in our office in Warsaw, Poland for 3 days per week.

Your role:

In this role, you are accountable for all Clinical Data Management (CDM) related deliverables across assigned global (Phase I-IIIb) trials or programs of varying complexity. As a CDM representative at study/program level, you provide CDM leadership and apply project management and operational expertise to strategically plan and deliver CDM activities, including timelines, resources, risk management, progress tracking, and stakeholder engagement.

You define and execute risk-based strategies for the collection, cleaning, coding, and quality assurance of eCRF and external data. In addition, you ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive review and validation activities. You are responsible for the quality of clinical databases/deliverables (incl. eCRF and external data) as well as the submission readiness of CDM deliverables and data packages (e.g. CDISC). As a primary CDM contact for HA submission activities, you support related preparations and meetings.

You manage CRO and vendor performance, including selection, assessment, and budget management for assigned trial(s). You also contribute to process improvements and to the development and maintenance of SOPs, work instructions, and best practices.

If assigned to a program, you apply your understanding of the compound profile to support consistent CDM processes and documentation across studies. You use your knowledge of CDASH, SDTM, and other recognised industry standards to ensure consistent implementation across the assigned program or indication. You may mentor colleagues and lead program-level activities that support 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
• Profound, long-standing experience in leading clinical data management activities in complex Oncology development projects (including large phase III trials) both on trial and program level
• Experience in working in different sourcing models with a focus on in-house models
• 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 varyingcomplexity; 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

Your Main Benefits

• Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card
• Work-Life balance: Enjoy additional paid days off, flexible working hours
• Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities
• Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!