Trial Vendor Senior Manager - Poland/ Spain/ Serbia/ Romania - FSP at Parexel

, , Spain -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

0.0

Posted On

06 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operation Processes, Vendor Management, GxP Regulations, ICH Regulations, Clinical Trial Design, Cross-Functional Teams, User Acceptance Testing, e-COA, IRT, Central Labs, Patient Recruitment, Retention, Imaging Reading, SOP Management, Global Training

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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: • 5+ 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 Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Responsibilities

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.