Principal, Data Manager - Consultant

Principal, Data Manager - Consultant

Apply locations

Europe-Remote, Boston-Remote

Time type

Full time

Posted on

Posted 7 Days Ago

Job requisition id

JR000283

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. All contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Job Description Summary

Job Description

ROLE

The Principal Data Manager leads and drives the DM team, acting as mentor and coach, and as the reference point for the Sponsor and the appointed person responsible for the project from a Data Management perspective. The role involves developing data collection specifications from all data sources.

The Principal Data Manager manages in-stream data flow activities, delivers a quality database according to the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, and makes recommendations for process improvements and standards development.

This role provides strategic input across the department, bridging scientific or medical knowledge with data management processes to ensure sound data collection tools, validations, and integration for clinical datasets.

KEY RESPONSIBILITIES

• Drive achievement of project milestones from study start-up to database delivery.
• Provide Data Management input into protocols.
• Design the Case Record Form and guide the CRF approval process.
• Define and develop Data Management Plans, Validation Plans, and annexes.
• Validate databases and computerized checks, including SAS listings or checks.
• Define UAT plans for EDC studies and execute testing to ensure quality eCRFs.
• Respond promptly to issues identified by the eCRF Helpdesk.
• Prepare CRF completion and study-specific data-entry guidelines and train staff.
• Perform term coding, raise queries, and manage data cleaning.
• Create and test import programs for external data.
• Perform data reconciliation and monitor study data progress reports.
• Define and execute QC plans, lead database release and freeze activities.
• Lead the DM team, coordinate staff, and prioritize work.
• Monitor project plans, escalate issues, and analyze data problems to develop solutions.
• Provide consultancy on Data Management processes and train team members.
• Maintain communication with sponsors, manage vendor relationships, and represent Data Management in meetings.
• Conduct other activities as required.

DESIRED QUALIFICATIONS & EXPERIENCE

• Degree in life sciences or related field, or at least 6 years' experience in data management in a pharmaceutical environment.
• Knowledge of Data Management processes and industry guidelines (e.g., ICH, GCP).
• Expertise in DM systems or processes, with recognized proficiency.
• Able to propose standards across studies and therapeutic areas.

TECHNICAL COMPETENCIES & SOFT SKILLS

• English proficiency, Good
• MS Office Suite, Good
• Professionalism, Trustworthiness, Ability to prioritize, Quality focus, Personable attitude, Willingness to learn, Team player, Stress management, Learning agility, Conflict management, Problem-solving, Verbal communication, Technical writing, Networking, Analytical thinking, Resilience, Influence, Feedback, Presentation skills, Commercial awareness, Talent development

Languages: English

Education: Bachelor's degree in Biology, Life Sciences, Pharmacology, or related field

Contract Type: Contingency Workforce