Senior Clinical Data Manager - sponsor dedicated

Fortrea; Polska; Remote; PLN 180,000 - 300,000; Full time

Benefits offered by this job

Pension contributions

Complimentary health insurance

Remote working allowance

Flexible working hours

Job summary

Fortrea is seeking a Senior Clinical Data Manager (home-based in Poland) to provide CDM leadership across projects, manage sponsor relationships, and mentor teams. The role spans complex, multi-site studies with strong client interaction and oversight of vendors to ensure data quality and regulatory compliance.

Applicants should have extensive CDM experience, RECIST understanding, and a solid grasp of the clinical trial lifecycle, operations, and biometrics within CRO/pharma environments.

Qualifications

• 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management
• At least 2 years of technical mentoring experience
• Extensive experience in clinical data management and 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, operations, biometrics, quality management, and systems applications

Responsibilities

• Provides CDM leadership for one or more assigned projects or indications.
• Lead studies with multi-site populations and complex protocol design.
• Demonstrates leadership in strategic planning and delivery of CDM deliverables.
• Manage vendor contracts, resourcing and budgets; oversee vendor performance.
• Act as primary CDM contact and coordinate with program team.
• Provide oversight of external providers or in-house teams for quality data.
• Identify and escalate CDM risks and drive improvement initiatives.
• Understand CDASH/SDTM standards and ensure program-wide consistency.

Skills

CDM leadership

Sponsor management

Mentoring

Clinical data management

Education

Life science degree

Tools

CDASH/SDTM

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.

Fortrea Is Proud To Be An Equal Opportunity Employer

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If, As a Result Of a Disability, You Require a Reasonable Accommodation To Complete Your Job Application, Pre-employment Testing, Job Interview Or To Otherwise Participate In The Hiring Process, Please Contact [e-mail]. Please note that this e‑mail address is only for job seekers requesting an accommodation. Please do not use this e‑mail to check the status of your application.

Learn more about our EEO & Accommodations request here.