Derks vacature klinisch-onderzoek

Site Oversight & Operations Relationship Lead

Derks & Derks Detachering

A temporary position at the clinical department of a large pharmaceutical company

Offer
  • working in an international and multicultural environment
  • working as a specialist in finance
  • temporary position until 31-01-2022
  • contract of Derks & Derks Secondment & Interim with the possibility to extend
Position

The Site Oversight & Operations Relationship Lead is the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Oversight & Operations Relationship Lead is the “face of the company” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the company’s reputation is that of “Partner of Choice.”

The Site Oversight & Operations Relationship Lead proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to being the main point of contact, the lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site communications and enhancing overall visibility into and confidence of quality of site-level activities.

Profile
  • a scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
  • BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience
  • solid knowledge of clinical development processes with strong emphasis on monitoring
  • cemonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
  • Site Management/Monitoring (CRA) experience (preferred)
  • project management experience preferred in the clinical development area
  • experience implementing centrally designed and developed initiatives on a local basis
  • skills in more than one language are an advantage in this role; English is required
Organisation

Our client is a leading, internationally operating, and innovative pharmaceutical company. They work intensively with other parties in the healthcare sector on a healthier world and a healthier Netherlands. They are able to achieve this by marketing innovative medicines, premium self-care products and impactful partnerships. They work in different business units, but a lot of knowledge and information is shared among themselves. For their Clinical Department they are looking for a Site Oversight & Operations Relationship Lead.

 

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-119-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Tagged as: Life Sciences

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