CRA II (Poland) - Sponsor-dedicated
Syneos Health
POL, Poland
před 3 dny

Description

Clinical Research Associate II, Sponsor-dedicated

Come discover what our 25,000+ employees already know : work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason we improve patients’ lives around the world.

Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

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.
  • Job responsibilities

  • Managing assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures.
  • Being the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries.
  • Performing remote and on-site monitoring activities to ensure compliance with protocol, ICH-GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
  • Conducting continuous monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned;
  • i.e., study start-up, recruitment, database analyses, closeout, etc.)

  • Conducting site visits including but not limited to selection visits, initiation visits, monitoring visits, close-out visits per SOPs and applicable regulations and documenting monitoring activities appropriately following Novartis standards;
  • Identifying issues at sites; resolving issues and escalating as appropriate;
  • Managing and maintaining information and documentation by updating all electronic systems (global and local) relevant to perform job functions;
  • Participating from audit organization and inspection readiness activities for monitoring and site related activities as required and ensuring implementation of corrective actions within specified timelines
  • Supporting the implementation of innovative processes and technologies;
  • Qualifications

    What we’re looking for

  • Fluent in both written and spoken English;
  • Scientific education (e.g. medical, pharmaceutical, biology, biotechnology etc.).
  • Previous monitoring experience (minimum 2 years) is essential gained in pharma / CRO.
  • Desirable, Previous experience in oncology trials or ready to monitor oncology trials.
  • Ability to travel domestically (a minimum of 50% overnight travel may be required).
  • Ability to anticipate potential issues and take appropriate actions with or without supervision.
  • We will value : good communication skills, ability to influence others and strategic thinking
  • 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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