パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Trial Vendor Senior Manager - Romania - FSP
応募 求人ID R0000034608 ロケーション ルーマニア 仕事内容At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.
Parexel FSP is recruiting for a Trial Vendor Senior Manager based in Poland, Spain, Serbia or Romania.
You will be accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. Collaborate with the VSM for the category specific responsibilities. Responsible for all activities for which no VSM is assigned with, and for all the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.
We expect from you:
• 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management (focused on Phase I/IIa (Early Phase))
• Excellent knowledge of GxP and ICH regulations
• Very good knowledge of clinical trial design and mapping to supplier requirements
• Experience working with diverse cross-functional teams and a matrix environment and driving organizational excellence
• Experience in User Acceptance testing for e-COA and IRT
• Knowledge of key deliverables that impact green light milestones and vendor readiness
• Experience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), and/or Imaging reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes)
Education: Bachelor's degree or equivalent degree is required, with advanced degree preferred.
For more details contact marta.kuniewicz@parexel.com
