Clinical External Data Acquisition Analyst

Overview The Clinical External Data Acquisition Analyst will create, review, and facilitate approval of external data format specification documents including, but not limited to, Data Transfer Specifications (DTS) and Electronic Data Transfer (eDT) for new service providers and data types. Coordinate with external and internal service providers, Information Technology (IT), and other supporting functions to validate external data transfers into the Company's data management system in accordance with detailed transfer specifications. During the in-life portion of a study, and in preparation for interim and end-of-study database locks, execute and review output of assigned reports to ensure completeness of data transfers; communicate and resolve external data loading issues with service providers and IT, as appropriate. Participate in process improvement initiatives, departmental meetings, and special projects as assigned. Supports audits and inspections as necessary. Responsibilities Create, review, and facilitate approval of external data format specification documents including Data Transfer Specifications (DTS) and Electronic Data Transfer (eDT) for new service providers and data types. Coordinate with external and internal service providers, IT, and supporting functions to validate external data transfers into the Company\'s data management system in accordance with transfer specifications. During study in-life portions and prior to interim and end-of-study database locks, execute and review output of assigned reports to ensure completeness of data transfers and resolve data loading issues with service providers and IT as appropriate. Participate in process improvement initiatives, departmental meetings, and special projects as assigned. Support audits and inspections as necessary. Qualifications, Skills & Experience Education: B.A. or B.S. degree, preferably in Medicine, Biochemistry, Pharmacy, Nursing, Bioengineering, Biological or Computer Sciences, or health care related discipline. Advanced / bilingual in English. Knowledge and Skills: Minimum 2 years’ experience in data management, medical research, or database design and development. Understanding of the clinical development process. Knowledge of database structures and available tools to manage, extract, and report data is preferred. Exceptional communication skills (oral and written) with the ability to communicate with both technical and business areas and external vendors. Exceptional organizational and problem-solving skills. Ability to establish and maintain good working relationships with different functional areas. Ability to multi-task, work independently under pressure and adapt to changing environments. Strong sense of urgency and customer focus. Desire and ability to learn new processes and technologies. Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR. Required Skills Accountability Adaptability Clinical Data Cleaning Clinical Data Management Clinical Development Clinical Research Communication Customer-Focused Data Analysis Database Development Data Processing Data Quality Assurance Data Review Data Validation Data Visualization Drug Discovery Process Early Clinical Development Electronic Data Capture (EDC) FDA Regulations Information Technology (IT) Support Learning Agility Medical Research 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) no Job Posting End Date 02/3/2026 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. Requisition ID: R #J-18808-Ljbffr