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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The primary functions of this position are:
- To write study specific data management plans
- To develop and maintain databases to collect and retain clinical data for laboratory challenge and clinical field trials for pharmaceutical and biologic veterinary compounds by following good Data Management practices:
- To collaborate with Clinical Research Assistant (CRA) on design of Case Report Forms / Data Capture Forms
- To establish data entry screens
- To program and run edit check and test integrity and consistency of the data
- To compare the two independently entered data ("confrontation") and collaborate with Clinical Research Manager (CRM) to resolve data entry differences
- To collaborate with CRM and CRA on data findings and resolve via data queries with the Investigator site
- To evaluate protocol deviations for effect on data analysis and interpretation
- Lock final data sets
- To track and transfer external data to primary database or warehouse
- To develop and implement processes to allow studies to be conducted paperless by using a Electronic Data Capture system
- To follow Good Clinical Practices (GCP), display unquestionable ethics, maintain patient and owner privacy, and protect confidentiality of company intellectual property
- To collaborate with Medical researchers, Veterinarians, Project Managers, Laboratory Scientists, Clinical Research Managers, Clinical Research Associates, Statisticians, Data Entry Administrators, Medical Writers, Pharmacovigilance, Auditors, Regulatory Affairs Managers and IT experts to professionally accomplish the above stated tasks in a proficient manner, exercising strong interpersonal skills.
Education Minimum Requirement:
- BS or BA in Data Management, Management Information Systems, Biological or Clinical Sciences, Statistics, or related field
Required Experience and Skills:
- 3 or more years experience in human or animal pharmaceutical industry.
- 3 or more years in a DM role or equivalent
- Expertise on the Clinsight software or another software dedicated to Data Management process
- Ability to understand and implement regulatory regulations and company procedures
- Ability to work independently and efficiently, in a project team environment
- Must be able to speak and write English.
- Proactive, pragmatic, flexible, service minded and able to work under (time) pressure
Preferred Experience and Skills:
- Ability to speak and write French helpful.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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.
Visa sponsorship is not available for this position.
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