Associate Director Clinical Data Manager

1 tydzień temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

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Associate Director Clinical Data Manager (all genders), Warsaw

Client:

Location:

Warsaw, Poland

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

3dfae022810a

Job Views:

3

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

This role can be done in a fully remote model. 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.

To be successful in this role, you would demonstrate accountability for all Clinical Data Management (CDM) related deliverables in assigned global (Phase I-IIIb) trials or programs of varying complexity. Provide leadership for assigned trial(s)/program(s), 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.

Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding). 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.

Who you are:
  1. Minimum of 10 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry.
  2. Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement.
  3. Proficient in contributing to non-study related initiatives e.g. process improvements, in addition to study assignments.
  4. Strong project management, analytical, communication, collaboration, and problem-solving skills.
  5. 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.
  6. Familiar with autonomously providing reports to senior management, including updates on financials, forecasts and timelines.
  7. Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management.
  8. 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, and a hybrid working model.

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.

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