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Date: Nov 9, 2017

Location: Haar, BY, DE

Company: MSD

Requisition ID: CLI006161

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 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.


For our Global Clinical Trial Organisation (GCTO) in Haar near Munich we are looking for a highly motivated and qualified

CRA Manager (m/f)

This position could be office- or home-based.


This role will be key to ensure business continuity in the area of monitoring in clinical research. Under the oversight of the Head of Monitoring Resources the person is responsible to manage a team of 6-12 CRAs and to ensure excellent study performance with strict adherence to local regulations, MSD SOPs and ICH GCP.



As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs.
The role will work at country level with other local stakeholder e.g. Clinical Research Manager to ensure alignment and development of the country capabilities. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.


 


Responsibilities include, but are not limited to:



  • Work allocation, staff development and performance appraisal.

  • Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

  • Work with CRA and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

  • Interacts with sites as needed to resolve site operational issues to meet commitments in a timely manner.

  • Attend local Investigator Meetings as necessary

  • Interface with GCTO partners on clinical trial execution.

  • Escalates site performance issues to Clinical Research Director.

  • People and Resource Management:


    • Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions

    • Support and resolve escalation of issues from CRAs

    • Liaise with local HR and finance functions as required

    • Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work

    • Provides training, support and mentoring to the CRA to ensure continuous development

    • Ensures CRA compliance to corporate policies, procedures and quality standards

Qualifications

 



  • Minimum of 2 years experience with CRA management

  • Minimum of 3 years experience as CRA monitoring clinical trials

  • Bachelors degree in Science or equivalent healthcare experience (required)
    Preferred: Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

  • Fluent in German and business proficient in English (verbal and written)

  • Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines

  • Ability to work independently and in a team environment

  • Excellent people management, time management, project management and organizational skills

  • History of strong performance

  • Skills and judgment required to be a good steward/decision maker for the company

  • Expertise in and excellent working knowledge of core trial management systems and tools

  • High emotional intelligence

  • Strong leadership skills with proven success in people management

  • Excellent interpersonal and communication skills, conflict management

  • Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)

  • Influencing skills


We are looking forward to receiving your application in English (CV and motivation letter).

Your role at MSD 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 MSD, we’re inventing for life.



Job: Clinical Research Monitor
Other Locations:
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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