Clinical Trial Supplies Mgr (Poland) - Sponsor-dedicated
Syneos Health
POL, Poland
před 5 dny

Description

Clinical Trial Supplies Manager

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

  • Outsourcing and coordinate clinical trial supplies based on the Trial outline (TO) for assigned clinical trials
  • Plan and coordinate timelines between relevant parties
  • Ensure optimal collaboration and processes with stakeholders
  • Compile and trace budget for assigned clinical trials
  • Prepare Request for Proposal / Service
  • Ensure protocol is consistent from a trial supplies point of view
  • Review and or approve documents in accordance with departmental Standard Operating Procedures
  • Sourcing / request relevant bulk (Investigational Medicinal Products - IMP, Non- Investigational Medicinal Products or Comparator)
  • Approving study related invoices
  • Determine relevant and correct master label text according to legislation
  • Identify and produce the new SOP s as applicable
  • Follow up on External Packaging Facilities used for labelling, packaging and distribution
  • Keep up to date with Authorities GMP, GDP and GCP requirements for packaging and distribution and ensure that these requirements are met
  • Participate in relevant cross organizational GMP, GDP and GCP related tasks (e.g. GMP, GDP and GCP committees and inspections)
  • Representing CTS in relevant Clinical Study Teams, Clinical Focus Teams and Quality Focus Teams
  • Comply with applicable Company Group Policies, Group Guidelines, Standard operating Procedures and Work Instructions
  • Biological IMP expert
  • Participate / Present at Investigator / Monitor Meetings globally
  • Quality management, Temperature handling, Deviations, Change requests
  • Distribution management
  • Ancillary Management, request for sourcing, set-up
  • MP Management, Forecasting, waste reduction, IMP Handling Manual, Destruction
  • Project Management. Lead optimization projects to benefit GCO
  • Import / Export management
  • Forecast calculations
  • Temperature Deviation expert
  • Qualifications

    What we’re looking for

  • MSc. Pharm., Pharmaconomy or similar education or experience
  • Knowledge of GMP, GDP and GCP
  • Fluent in oral and written English
  • Ability to investigation the issues
  • Processing Details
  • Ability to working with structuring tasks
  • Very good communication skills and ability to sharing the necessary information
  • Showing Resilience
  • Ability to building good relationships
  • Stakeholder Focus
  • Integrity and trust
  • 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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