Functional Area Geography Associate Director, GDMS Clinical Data Management

Caraway Therapeutics, Inc.; Województwo mazowieckie; Hybrid; PLN 420,000 - 540,000; Full time

Job summary

Caraway Therapeutics, Inc. seeks an Associate Director in GDMS Clinical Data Management to oversee day-to-day operations within the assigned geography. You will ensure compliance, quality delivery, and staff development across sites in a hybrid work setting in Poland.

You will lead data-management resources, drive performance metrics, and partner with leaders to implement standards and best practices while maintaining inspection readiness. Fluency in English and strong leadership are essential.

Qualifications

• Advanced degree required with 4+ years of data management experience in clinical trials.
• Minimum 2 years of people leadership or matrix leadership experience.
• Strong knowledge of GCP, 21 CFR Part 11 and data management standards.

Responsibilities

• Lead and oversee Data Management operations within the geography, ensuring quality and compliance.
• Drive resource planning, workload balancing, and performance monitoring with stakeholders.
• Ensure implementation of GDMS/GCTO standards and regulatory requirements.
• Build, develop, and lead high-performing teams with coaching and talent development.
• Lead hiring, workforce planning, and budget management.

Skills

Stakeholder management

People leadership

Strategic thinking

Change management

Communication

Education

Master's or Doctorate degree in Life Science/Data/IT/PM/Business

Job description

Job Description

The Functional Area Geography Associate Director, GDMS Clinical Data Management oversees day-to-day data-management operations and resources within the assigned geography. The role ensures operational efficiency, compliance, and quality delivery, supports regional strategy and resourcing, and partners with other leaders to promote consistent practices and staff development across sites.

Key Responsibilities

• - Lead and oversee Data Management operations within the assigned geography, ensuring quality, compliance, operational excellence, and inspection readiness.
• - Drive resource planning, workload balancing, and performance monitoring in partnership with operational stakeholders.
• - Ensure consistent implementation of GDMS (Global Data Management and Standards)/GCTO (Global Data Clinical Operations) standards, regulatory requirements, and best practices.
• - Manage operational risks, support continuous improvement, change initiatives, and cross-regional alignment.
• - Build, develop, and lead high-performing teams through coaching, onboarding, talent development, and performance management.
• - Lead hiring, workforce planning, employee engagement, and budget management.
• - Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.

Technical Expertise

• - Strong knowledge of clinical data management, clinical trial lifecycle including study start-up processes, and industry regulations (GCP, 21 CFR Part 11).
• - Experience with data standards, data flow, quality oversight, and inspection readiness.
• - Proficiency in resource planning, operational metrics, and continuous improvement methodologies.
• - Ability to drive high-quality clinical data design, validation, delivery, and audit preparation.

Leadership & Professional Skills

• - Exceptional stakeholder management, communication, influencing and presentation skills across global, cross-functional environments.
• - Proven people leadership with a strong focus on coaching, mentoring, talent development, and team performance.
• - Ability to lead through influence, foster collaboration, and drive alignment without direct authority.
• - Strong decision-making, problem-solving, adaptability, and resilience in dynamic environments.
• - Demonstrated success in leading organizational change, innovation, and continuous improvement.
• - Fluent English with excellent written and verbal communication skills.

Enterprise Leadership Skills

• - Execution Excellence | Drives reliable, high-quality delivery within their team - developing core functional capabilities and KPI-driven measurement approaches (e.g., time-to-lock, query rates, error reduction) to track progress, improve outcomes, and support consistent, submission-ready outputs across studies.
• - Strategic Planning | Thinks strategically within the assigned scope and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT.
• - Networking & Partnerships | Builds and sustains strategic internal and external relationships (cross-functional leaders, service providers, alliance partners, customers) within the assigned scope to advance functional area objectives.

Qualifications & experience

• - Advanced Degree (Masters or Doctorate) (preferred in Life Science, Data, Information Technology, Project Management or Business) with 4 years of related industry experience in data management, including demonstrated experience in clinical data management, clinical trial operations, and managing large diverse teams, and minimum 2 years of people leadership or management experience (direct or matrix leadership).

Additional location(s) Compensation Information:

Required Skills:
Clinical Data Management, Clinical Development, Clinical Research, Clinical Trials, Data Analysis, Data Extraction, Data Integration, Data Validation, Delivery Management, Enterprise Leadership, Good Clinical Practice (GCP), People Leadership, People Management, Pharmacovigilance, Project Management, Stakeholder Management, Strategic Planning, Strategic Thinking

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/25/2026
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