Senior Specialist, External Data Manager, GDMS Clinical Data Management

·         Maintain compliance with SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization - Good Clinical Practice), and protocol-specific processes.

Archive required documentation in the eTMF (electronic Trial Master File), including service provider correspondence, mapping specifications, and transfer logs, to ensure traceability and inspection readiness.

Qualifications & experience

· Bachelors of Arts or Sciences (preferred in Nursing, Pharmacy, Life science, Data / Information technology or Medical Technology; or equivalent educational experience)

· Minimum 5 years of experience working in data management, clinical trial operations or related field.

·Desirable Masters or Doctorate **(**preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 2 years of experience working in data management, clinical trial operations or related field.

Technical skills

·       Working understanding of the clinical development process and trial data flow.

·       Proficiency with electronic data capture (EDC) platforms, other data acquisition tools (e.g. eCOA [electronic Clinical Outcomes Assessment]) and external data integrations, including authoring edit check and reconciliation specifications (and/or programming where applicable).

·       Deep knowledge of appropriate application of standards and terminology; partners effectively with Standards on new terms and updates.

·       Experience preparing complete, well-organized documentation for audits and inspections.

·       Advanced authoring and maintenance of external data specifications with clear implementation guidance for service providers and IT; manages versioning and change control.

·       Deep experience executing reconciliation (cross-system completeness and consistency), end-to-end (E2E) data lineage and traceability, and reference-range or clinical plausibility checks to ensure accurate, audit-ready external data.

·       Proven RCA of load and mapping defects; defines corrective actions and contributes to UAT (User Acceptance Training) for external data feeds.

·       Trial-level metrics literacy (timeliness, completeness, defect rates) to target and verify improvements.

Non-technical skills

·       Communicates effectively (oral and written) with technical and business partners and external service providers; translates technical topics for non-technical stakeholders and adapts style to audience.

·       Manages difficult conversations constructively; negotiates timelines and quality expectations.

·       Demonstrated ability to provide mentorship to junior team members.

·       Demonstrated ability to lead day-to-day activities; drives issue triage to closure and coordinates stakeholders.

·       Prioritizes independently; escalates with context, impact, and recommendation.

·       Delivers crisp status, decisions, and blockers; maintains decision logs.

Enterprise Leadership Skills

·       Networking & Partnerships | Develops and sustains productive relationships within and across functions to enable collaboration, alignment, and the achievement of shared goals.

·       Executional Excellence | Drives timely, proactive execution in line with compliance standards, overcoming barriers and delivering strong results that advance broader team and business priorities.

Ownership & Accountability |Establishes high standards for performance, takes responsibility for delivering on commitments, and ensures work is executed with accountability, quality, and follow-through.

Additional location(s) Compensation Information:

Required Skills:

Adaptability, Adaptability, Clinical Data Management, Clinical Research, Communication, Continuous Improvement Techniques, Data Analysis, Database Concepts, Database Lock, Data Loading, Data Management, Data Operations, Data Quality Assurance, Data Reporting, Data Review, Data Standards, Data Strategies, Data Validation, Electronic Trial Master File, Good Clinical Practice (GCP), Inspection Readiness, Leadership, Medical Terminology, Performance Metrics, Project Coordination {+ 6 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/2/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.