Job Description
The Clinical External Data Acquisition Analyst will create review and facilitate approval of external data format specification documentsincluding 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 Companys 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 morePreferred Skills:
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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 BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more