Clinical External Data Acquisition Analyst
hace 11 horas
Job Description
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), Electronic Data Transfer (eDT), for new service providers and data types.
Coordinate with external and internal service providers, Information Technology (IT), and the other supporting functions to validate external data transfers into 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.
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:
Minimun 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 the 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, 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, Orthoptics, Patient Education {+ 4 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noJob 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:R382652
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