Clinical Research Associate Manager
MSD
Warsaw, PL
4 d. temu

CLI008701

Have you heard about MSD?

MSD is an innovative, global healthcare leader committed to improving health and well-being in 140 countries around the world.

We continue to focus our research on conditions that affect millions of people around the world - diseases like Alzheimer's, Diabetes and Cancer -

while further expanding our strengths in areas such as vaccines and biology.

We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

MSD 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. Our research division is a true scientific research facility of tomorrow, and will take MSD’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.

Opportunity offered : Clinical Research Associate Manager

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Monitoring Resources or the CRD,the person is responsible to manage a team of 6-

14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, companySOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

Responsibilities include, but are not limited to :

Key Responsibilities :

The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities.

The role will collaborate with country PLMs to ensure alignment across all monitoring functions. 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 CRAs, PLMS 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 or CRA operational issues to meet commitments in a timely manner in coordination with thestudy CRM.
  • Attend local Investigator Meetings if requested to.
  • Interface with GCTO partners on clinical trial execution.
  • Escalates site performance issues to CRM and Clinical Research Director CRD.
  • People and Resource Management : o 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. o Ensures CRA compliance to corporate policies, procedures and quality standards
  • Qualifications

    Expected Qualification of YOURS :

    We are seeking professionals with the following qualifications, skills and Experience :

  • Minimum of 5 years experience with in Clinical Research
  • Minimum of 3 years’ experience as CRA monitoring clinical trials
  • Bachelor’s degree in Science
  • Nice to have would be advanced degree, (e.g. BA / BS or higher) with a strong emphasis in science and / or biology
  • 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
  • Fluent in Local Language andbusiness 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
  • Expertise in and excellent working knowledge of core trial management systems and tools
  • High emotional intelligence
  • Strong leadership & influencing 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)
  • We offer :

  • Competitive remuneration
  • Position in a leading global healthcare company
  • Challenging career
  • Professional growth based on performance
  • Innovative and flexible working environment
  • Wide range of benefits
  • 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.

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