Senior Clinical Data Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in Poland.

📋 Description

• Provides leadership in Clinical Data Management (CDM) for one or more designated projects or indications, based on the size and scope of the project.

• Oversees studies that include healthy volunteers and patient populations, multi-site research, intricate protocol designs, client management, or expedited timelines.

• Exhibits leadership and operational proficiency in strategic planning and execution of CDM deliverables at both program and project levels.

• Manages and supervises vendor contracts, resource allocation, budgets, and vendor performance for the assigned programs and projects.

• Engages in communication and negotiations with team members at the program level.

• Acts as the main point of contact for Clinical Data Management.

• Provides oversight and expertise to external service providers or in-house teams to ensure the delivery of quality data in accordance with study model procedures and standards.

• Leads proactive risk management and addresses issues related to Clinical Data Management enhancements or technology.

• Develops an understanding of CDASH, SDTM, and other recognized industry standards, and their implications for programming teams to ensure adherence to program-level standards.

⛳️ Requirements

• University or college degree, preferably in life sciences, pharmacy, or a related field.

• At least 8 years of combined experience in early or late-stage Data Management.

• A minimum of 2 years of direct experience in sponsor management.

• At least 2 years of experience in technical mentoring.

• Extensive background in clinical data management.

• Experience leading studies within a CRO or pharmaceutical environment.

• Familiarity with RECIST criteria.

• Exceptional oral and written communication and presentation skills.

• Comprehensive knowledge of the clinical trial process, data management, clinical operations, biometrics, quality management, and systems applications that support operations.

• Practical understanding of the regulatory obligations and relationship between the CRO industry and pharmaceutical/biotechnology companies.

🏝️ Benefits

• Highly competitive compensation packages.

• Pension contributions.

• Complimentary health insurance plans.

• Remote working allowances.

• A genuine work-life balance.

• Flexibility in working hours.

• Comprehensive onboarding supported by a personal mentor.

• Opportunities for mentoring, training, and personalized development planning.