Trial Vendor Senior Manager Job at Parexel

Job Description

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.

Job Responsibility

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
Responsible for all the service deliveries after Study Start-up when the VSM is no longer assigned to the study

Requirements

7+ years working experience and excellent knowledge of the clinical operation processes and vendor management (focused on Phase I/IIa (Early Phase))
Worked in a global environment or part of a global study team, having managed relationships with key stakeholders
First-hand experience of vendor management and oversight as well as being the primary point of contact for vendor management activities across the lifecycle of global clinical trials
Have experience with direct vendor management & oversight including (but not limited to) IRT/eCOA/Central Labs/Cardiac/ECG/PR&R on a global level
Management of vendor performance, quality, compliance, timelines, and budget
Experience with vendor-related risk management and tracking, issue escalation, and process improvement
Collaboration with cross-functional teams (e.g., Study Leadership, Data Management, Medical, procurement etc.)
Strong communication, negotiation, and stakeholder management skills
Knowledge of GxP/ICH guidelines and operational processes within clinical studies
Experience with study start-up activities, translating protocol/concept sheet to vendor specifications, collecting documents for submissions, UAT (eCOA, IRT etc.), site readiness, and systems/tools
Experience handling multiple vendors in parallel, including how they manage complexity and competing priorities
Their personal role in UAT such as identifying issues from both patient and trial operational perspectives
Following up with vendors for resolutions before the go-live date and managing fixes and any re-testing prior to go-live
Close-out activity and reconciliation experience
Invoice and vendor budget reconciliation oversight is preferrable
Audit experience is preferrable
Sponsor/CRO/vendor transition studies experience is preferrable
Protocol amendment experience
Education: Bachelor's degree or equivalent degree is required, with advanced degree preferred

Nice to have

Invoice and vendor budget reconciliation oversight is preferrable
Audit experience is preferrable
Sponsor/CRO/vendor transition studies experience is preferrable
Protocol amendment experience

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Trial Vendor Senior Manager

Job Description

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Requirements

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