Sign In
 [New User? Sign Up]
Mobile Version

Senior Specialist, Clinical Research

Merck


Location:
Rahway, NJ
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
CLI006206
Merck
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Job Title: Senior Specialist, Clinical Research  - CLI006206

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 


Responsible for supporting the portfolio for external data processing setup and in-life activities, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines. These responsibilities includes responsibility for larger, more complex or higher risk protocols: Working with vendor Qualification teams to perform vendor qualification as an Data transfer Subect Matter Expert, working with Study Teams to develop and obtain approval for the data format specifications for each data type in every study; coordinate/perform User Acceptance Testing (UAT) for External Data Vendor studies and ensure production data files are received; external data processing during in-life phase of studies including error remediation and running/reviewing EDAO run evd reports and cumulative compares as established milestones; communication with external vendors and internal cross-functional groups to resolve output from data queries used to perform data quality assessment; and escalation of external data issues with potential impact on the schedule. Primary customers are Global Data Management Services and Clinical Research.



Qualifications

Education: 

  • At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Required: 

  • At least 3 years’ experience in data management, medical research, or database design and development.

Preferred:

  • An overall working knowledge 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 change environment with flexibility.
  • 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 Part 11.


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            

            



Job Clinical Research Generic

Primary Location NA-US-NJ-Rahway

Other Locations 

Employee Status Regular

Number Of Openings 2

Powered By

Featured Jobs[ View All ]