MSD Animal Health Innovation GmbH

Clinical Research Manager Animal Health (m/f)

Online seit
15.05.2018 - 09:15
Job-ID
GOE-2018-05-14-183058
Jobtyp
Absolventenjobs

Job-Beschreibung

MSD 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 MSD has codified its 125-year legacy.

MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

To support our team in Schwabenheim and Madison we are looking for a

Clinical Research Manager Animal Health (m/f)

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.

Your tasks:

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 MSD 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 Clinical Research Manager:

  • 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 report
  • 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

Anforderungsprofil

  • DVM or equivalent veterinary degree
  • First experience as a veterinary or in a similar clinical research role
  • Fluent written and oral command of English and German language
  • Good communication skills
  • A strong ability in scientific writing
  • Proficient in MS Office applications

Art der Beschäftigung

Vollzeit

Vergütung

Attraktives Gehaltspaket inklusive umfangreicher Sozialleistungen

Firmen- und Kontaktdaten

Name des Unternehmens
MSD Animal Health Innovation GmbH
Ansprechpartner
Frau Anna Smakowska
Einsatzort
Zur Propstei
55270 Schwabenheim
Deutschland
E-Mail
Webseite

Weitere Informationen

Zeitraum der Beschäftigung
unbefristet, ab Montag, 14. Mai 2018