Clinical Data Management Sr. Specialist

Job description

Job Description Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Company Standard Operating Procedures (SOPs) and ICH-GCP guidelines. The role also looks for candidates with relevant experience in adjacent clinical, monitoring, operational, or technology areas, particularly where such experience strengthens the organization’s ability to support RBQM, AI-enabled capabilities, medical monitoring, site monitoring, and SDV-related needs. In Early Stage Development (ESD), the SCDM may have sole responsibility for these activities; in Late Stage Development (LSD), the SCDM’s execution of these activities may be overseen by a Lead Clinical Data Manager (LCDM) or other manager.Education and Experience:At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 1 year professional experience in clinical data management;ORAssociates Degree with at least 2 years’ professional experience in clinical data management;ORHigh School Diploma (or equivalent) with at least 3 years’ professional experience in clinical data management.Preferable knowledge and skills:Highly self‑driven, with advanced expertise in work planning, prioritization, and time management. Fluent professional English, written and spoken, for global and cross‑functional collaboration. Strong end‑to‑end understanding of the clinical development lifecycle. Advanced knowledge of clinical practice and precise use of medical terminology. Solid command of regulatory frameworks, SOPs, and compliance requirements. Proven ability to perform under pressure in fast‑paced, changing environments. Clear and effective communicator across technical, clinical, and business stakeholders. Demonstrated leadership and decision‑making contribution, with confidence to challenge and influence. Hands‑on expertise in Data Validation component design and development. Proven capability to translate protocol requirements into high‑quality Data Management specifications. AND for External CandidatesRelevant experience in adjacent clinical, monitoring, operational, or technology roles such as CRA, CSSM, or IT. Working knowledge of RBQM, AI-enabled capabilities, medical monitoring, site monitoring, and SDV. Ability to apply cross-functional experience to strengthen data quality, risk oversight, and stakeholder collaboration. -Fluent oral and written English skills. Required Skills: Adaptability, Adaptability, Clinical Analytics, Clinical Data Cleaning, Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research, Communication, Competency Management, Customer-Focused, Data Analysis, Database Development, Data Management, Data Processing, Data Quality Assurance, Data Review, Data Standards, Data Validation, Data Visualization, Decision Making, Early Phase Clinical Trials, Electronic Data Capture (EDC), Learning Agility, Pharmacovigilance {+ 8 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 09/29/2026*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.