Site Care Partner - Romania - 0.5 FTE / permanent contract - FSP Oradea

Site Care Partner - Romania - 0.5 FTE / permanent contract - FSP
Oradea
Oradea, Bihor County, Romania

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Site Care Partner (SCP),
- based and sponsor dedicated, in Romania for 0. 5 FTE and permanentcontract. In this role you will be the main Client point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site.

We are looking for
- working, talented,
- caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of
- term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and
- term prospects.

Our Site Care Partners work from their home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

The most significant aspect of this position is that

• the Site Care Partner I (SCP I) is the “face of the client” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle.

• the SCP I is the main client point of contact for investigative sites; accountable for site start up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site.

• the SCP I contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision

From you we expect

• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology

• In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 7 years of clinical research experience and/or quality management experience.

• Skills in more than one language are an advantage in this role; English is required

• Solid knowledge of clinical development processes with strong emphasis on monitoring

• Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)

• Site Management/Monitoring (CRA) experience needed. +7 years as CRA/ SCRA.

• Project management experience preferred in the clinical development area

• Ability to lead, troubleshoot and influence for delivery

• Experience implementing centrally designed and developed initiatives on a local basis

• Demonstrated knowledge of quality and regulatory requirements for applicable countries

• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation

• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, Food and Drug Administration (FDA), or
- specific regulatory environment

• Demonstrated experience in site activation and startup

• Demonstrated networking and relationship building skills

• Demonstrated ability to manage projects and
- functional processes

• Availability to travel regularly within country and region is required (3 - 5 visits per month)

For an immediate interview, please contact marta. kuniewicz@parexel.com

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