Senior Clinical Data Manager - sponsor dedicated

Fortrea; Polska; Remote; PLN 240,000 - 360,000; Full time

Benefits offered by this job

Pension contributions

Complimentary health insurance plans

Remote working allowances

Work life balance

Onboarding and mentorship

Job summary

Fortrea in Poland is seeking a Senior Clinical Data Manager to lead CDM on sponsor-dedicated studies, with oversight of multi-site trials and vendor contracts. The role supports flexible, home-based work and a strong mentorship environment.

You will drive data quality and CDM standards, coordinate cross-functional teams, manage timelines and risks, and mentor junior staff while ensuring regulatory compliance and collaboration with CRO partners.

Qualifications

• 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience.
• Extensive experience in clinical data management and leading studies in a CRO/Pharma setting.
• Understanding of RECIST criteria.

Responsibilities

• Provides CDM leadership for one or more assigned projects or indications depending on size and scale.
• Lead studies including healthy volunteer and patient populations, multi-site, complex protocol design, and client management.
• Demonstrates leadership in strategic planning and delivery of CDM deliverables at program or project level.
• Oversee vendor contracts, resourcing and budget, and vendor performance for programs and projects.
• Communicate and negotiate with Program level team members; primary CDM contact.
• Provide oversight of external service providers or in-house teams to deliver quality data.
• Proactively manage risks and escalate issues related to CDM improvements or technology.

Skills

CDM leadership

Sponsor management

Mentoring

Excellent communication

Regulatory knowledge

RECIST knowledge

Education

University/college degree (life science, pharmacy or related subject preferred)

Job description

Senior Clinical Data Manager – sponsor dedicated (home-based in Poland)

Joining Fortrea’s Clinical Data Management sponsor dedicated team will offer a rewarding career, a chance to work in an energetic & team-oriented workplace and exposure within a world-leading team. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

What You Can Expect From Us

• Exposure to high profile global studies with
• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
• A genuine work life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor

What You Will Do

• Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project.
• Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
• Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level.
• Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects
• Communicates and negotiates effectively with all other Program level team members. Primary point of contact for Clinical Data Management (CDM)
• Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards;
• Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology
• Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.

Your profile

• University/college degree (life science, pharmacy or related subject preferred)
• 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience.
• Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting.
• Understanding of RECIST criteria.
• Excellent oral and written communication and presentation skills.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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