Principal Clinical Data Manager

eClinical Solutions; Deutschland; Vor Ort; EUR 109.832 - 127.405; Vollzeit

Benefits dieser Stelle

Top remote-work award

People-first culture

Learning and growth

Diversity and inclusion

Zusammenfassung

eClinical Solutions seeks a highly experienced Principal Clinical Data Manager to lead data management across the full data lifecycle for complex clinical trials, guiding protocol builds, CRF design, data cleaning and QA. The role requires strong leadership, cross-functional collaboration with operations, biostatistics and programming teams, and knowledge of industry standards.

The candidate will oversee data management strategies, ensure regulatory compliance (ICH/GCP, 21 CFR Part 11), and

Qualifikationen

• Bachelor’s degree or higher in health science or related field; master’s preferred
• 10+ years' experience in Pharmaceutical/Biotechnology with Clinical Data Management or equivalent consulting role
• CCDM Certification preferred
• Strong project management experience and team leadership
• Experience with agile and six sigma methodologies
• Strong consulting and client relationship management skills
• Proficiency in English (verbal and written)
• Proficiency with MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred)
• Exposure to CDISC guidelines and standards

Aufgaben

• Primary representative for eClinical Solutions and sponsor data management interaction, ensure DM process is followed and deliverables meet quality and timelines within approved scope
• Function as DM subject matter expert providing guidance on data management best practices, technology, and solutions
• Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
• Define specifications and collaborate with technical team on configuration of elluminate for data cleaning strategy and oversight activities
• Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate modules
• Perform quality oversight and data trending via elluminate reporting and analytics to identify risks and develop mitigation and data cleaning strategies
• Collaborate with technical and engineering teams on tech enabled solutions in areas for process and efficiency improvement
• Collaborate with functional managers and training team to deliver training
• Other duties as assigned

Kenntnisse

Project management

Leadership

Analytical thinking

Communication

Ausbildung

Bachelor’s degree in health science

Master’s degree in science (preferred)

Tools

MS Project

MS Excel

EDC systems

Jobbeschreibung

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

You will make an impact: Highly skilled and seasoned Principal Clinical Data Manager with extensive experience in the management and oversight of clinical data throughout the entire data lifecycle. Proven track record of successful leadership in designing, implementing, and managing data management strategies for complex clinical trials in adherence to industry standards and regulatory requirements. Strong leader effective in managing and fostering cross-functional collaboration among clinical operations, biostatistics, and programming teams to achieve seamless integration of data management activities to drive operational efficiencies and meet project timelines. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.

Your day to day:

• Primary representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope
• Function as DM subject matter expert providing guidance on data management best practices, technology, and solutions
• Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
• Define specifications and collaborate with technical team on configuration of elluminate® for data cleaning strategy and oversight activities
• Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate® modules
• Perform quality oversight and data trending via elluminate® reporting and analytics to identify risks and develop mitigation and data cleaning strategies
• Collaborate with technical and engineering teams on tech enabled solutions in areas for process and efficiency improvement
• Collaborate with functional managers and training team to deliver training
• Other duties as assigned

Qualifications:

• Bachelor’s degree or higher (master’s in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline preferred
• 10+ years' experience in Pharmaceutical/Biotechnology industry with Clinical Data Management or equivalent consulting role preferred
• CCDM Certification preferred
• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
• Prefer experience with agile and six sigma methodologies
• Strong consulting and client relationship management skills
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred)
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards

Benefits and Culture:

• eClinical Solutions is a winner of the 2025 Top Workplaces USA Award for Remote Work
• We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/
• eClinical Solutions is a people first organization
• Our inclusive culture values the contribution that diversity brings to our business
• We celebrate individual experiences that connect us and that inspire innovation in our community
• Our team seeks out opportunities to learn, grow and continuously improve
• Bring your authentic self, you are welcome here

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Pay Range US Pay Ranges $125,000 - $145,000 USD