Currently we are looking for candidates for the position of:

 

Manager of Monitoring

Location: Warsaw

 

Your Key Responsibilities as a Manager of Monitoring will include:

  • Management of 8-12 insourced staff (Country Lead Monitors, Senior CRAs, SRAs and CTAs) and providing expertise and strong leadership and maintains a motivated and competent staff
  • Operational activities related to global and country procedures applied in the site management of applicable Phase I and all Phase II-IV clinical trials
  • Quality Oversight - Oversees Corrective Actions / Preventive Actions (CAPAs) of assigned insourced staff to ensure timely and sufficient resolution
  • Participation in Audit Review Meetings and reviews all responses to audit findings prior to submission
  • Involvement in process improvement (identifying and proposing solutions for opportunities to Country Head Global Monitoring and Site Management, and communicating best practices to entire monitoring staff)
  • Audits responses’coordination with Global Quality Management.Proactively identifying actions to be taken at the country level toimprove upon audit and inspection findings
  • Contribution to delivering Training programs as well as coordinating all job-specific training needs for insourced CLMs, Senior CRAs, CRAs and CTAs
  • Contribution to development of country clinical investigator networkto support the portfolio needs for clinical trials
  • Collaboration withMedical Science Liaison management to cultivate and enhance clinicalinvestigator relationships to support business strategy

 

 

To be considered for this position, you will be able to demonstrate:

  • University’s degree (or equivalent) with 8 years’ relevant healthcare experience including 4-6 years’ relevant clinical development or clinical operations experience
  • In-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirements
  • Strong leadershipand collaborative skills.
  • Administrative, financial, and technical skills
  • Effective verbal and written English communication skills
  • Ability to work effectively within a multi-cultural, global, matrix organization

 

 

What we offer:

  • Excellent opportunity to work for a company with focus on personal and professional development
  • Challenging work environment, opportunity to contribute to the substantial growth of the organization
  • Highly motivated team and international corporate culture
  • Comfortable working conditions
  • Attractive salary, bonus
  • Complex medical care and individual life insurance

 

If you are interested in this role and you fulfil the requirements set above,
do not hesitate to send your CV

 

 

 

Please enclose the following sentence: “I hereby agree for processing the following personal information strictly for recruitment purposes in accordance with the regulation regarding the protection of personal data passed on the following date: 29.08.1997, Dz. U. nr 133 poz.833”.