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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Site Excellent Partner - FSP

Job ID 73753BR Taipei, Taiwan
ExecuPharm (a Parexel Company) are currently looking for an clinical operations professional to join our expanding team in Europe, this position is solely dedicated to one of our longest standing clients, a well known global biopharmaceutical company.

Position Purpose:

The Site Relationship and Excellence Partner (SREP) is the main Client 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

Primary Duties:
  • Responsible for relationship building and management
  • Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions
  • Provide country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices
  • Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics
  • Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for targeted sites
  • Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Client colleagues
  • Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management
  • Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks
  • Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control
  • Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standards
  • Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs
  • Work with CRO CRAs, and other CRO colleagues as appropriate, to drive resolution of oversight issues
  • Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of Corrective and Preventative Actions (CAPAs) to address these
  • Protocol Site Oversight
  • Site and Study Management Interface

Qualifications

Qualifications :

More about you
  • 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 + 5 years of clinical research experience and /or quality management experience
  • 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 (preferred)
  • Project management experience preferred in the clinical development area
  • Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, Food and Drug Administration (FDA), or country-specific regulatory environment
  • Availability to travel regularly within country and region is required

A little about us

For over 30 years, we at Execupharm have been an industry leader in providing innovative, flexible and customized outsourcing solutions. Our Functional Service Provider (FSP) team was established to help clients accelerate pipeline development.

With over 5,000 Global FSP resources, with an additional 25,000+ pre-screened potential candidates in our system, we are available to partner with you to provide tailored solutions that address your unique needs.
In 2016 Execupharm became part of Parexel, focusing on continuing to deliver amazing FSP solutions to clients globally.
Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That’s Parexel. We’re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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