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CRA II (Sweden) - Sponsor-dedicated

Employer
Syneos Health
Location
Client-Based, SWE
Salary
Competitive
Start date
14 Apr 2021
Closing date
16 Apr 2021

Job Details

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Summary:

Here at Syneos Health we are currently recruiting for a CRA II level to be based in office (3 days per week) in Solna and work closely with one of Global Pharmaceutical company.

Job Details:
  • Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:

o Overview the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.

o Ensure quality of data submitted from study sites and assures timely submission of data. Train study site personnel on the protocol and applicable regulatory requirements.
  • Facilitate Quality Assurance Audit processes as indicated.
  • Report monitoring activities and study site conduct accurately and completely.
  • Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
  • Negoti ates investigator/ hospital agreements with stakeholders.
  • Uses multiple technologies to maintain open and frequent communication with internal & external customers.
What we're looking for
  • Minimum of 3 years of clinical monitoring.
  • Start-up experience will be asset.
  • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
  • Good written and verbal communication skills. Written and verbal fluency in English and local language.
  • Previous experience with electronic data capture systems is desirable

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

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