Clinical Research Manager (Animal Health):
Merck

CLI006947-en_US
Merck
Madison New Jersey
Pharmaceutical
Description
Requisition ID: CLI006947

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.
 
The primary function of the Clinical Research Manager (CRM) position is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate to be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.

The CRM acts primarily as clinical study team leader (CSTL) and has overall responsibility for a study. Specifically, the CRM has the following tasks and responsibilities:
  • Design and organization of paper and Electronic Data Capture (EDC) clinical studies –irrespective of their complexity - that meet scientific and regulatory requirements. This includes the setting of objectives, budgetary aspects, resources, timelines and the study protocol,
  • Provide overall leadership and support to the study team.
  •  Prepare the Study Protocol.
    • Make the final selection of the Investigators, laboratories and/or CROs for the study.
    • Apply for the necessary study permits and licenses – with support of local regulatory staff and GRA – within the specified study timeline
    • Train the study team on the Study Protocol, as appropriate.
    • Ensure the timely selection and ordering of (I)VP and CP.
    • Ensure compliance of the administrative aspects of the study (budgets and agreements) with the applicable Merck policies and procedures.
    • Plan and coordinate the monitoring and data management activities of each study.
    • Ensure that the study is conducted according to legal requirements, GCP and the applicable internal policies and procedures.
    • Prepare the Final Study Report.
    • Maintain contact with the all stakeholders (project leader, RA, Quality Assurance etc.) and keeps them informed of the study progress. May be the GCR representative in the project team.

In addition the CRM:

  • Can assume responsibility for certain monitoring and data management tasks (e.g. User Acceptance Test of electronic CRFs).
  • Can monitor clinical studies under the leadership of other CSTLs.
  • Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
  • Perform quality control inspections of study protocol, study documentation files and reports as appropriate.
  • When required, serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities.
  • Prepares Efficacy Critical Summaries and expert reports.
  • Supervise trainees and provide mentorship and support to other GCR staff as appropriate.
  • Supports GRA in the defence of approved products.
  • Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
  • Conducts post-marketing studies.
  • Prepares scientific publications (articles, oral communications, posters) according to the need of the company.
Qualifications

Education:
  • DVM and/or PhD in veterinary/animal science required

Required:

  • DVM and/or PhD with a minimum of  1 year of experience in clinical research or similar research role.
  • Experience in a clinical study related role.
  • Good written and oral command of English language and if possible of German and/or French.
  • Good communication skills.
  • A strong ability in scientific writing.
  • Proficient in MS Office applications

Preferred:

  • Both DVM and PhD preferred.

 

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruitng process, please send a request to 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.
 
Visa sponsorship is not available for this position.
 
For more information about personal rights under Equal Employment Opportunity, visit:
 
            EEOC Poster
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MAH2018


Job: Clinical Research (Non-M.D.)
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement