Assoc Clin Project Mgr

Job Description:

Responsibilities

• 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.
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Qualification & Experience     

• Any lifescience education background
• Minimum 3–5 years of clinical trial experience as PM / GTM - i.e. to have the chance to face different situations and demonstrate experience
• CRA experience not counted toward the 3–5 years PM requirement
• Could consider CRA experience + 2-3 years clinical trial experience as PM / GTM - ensuring CRA experience can be extrapolated to demonstrate relevant skills
• Global experience is required – understand all CTT roles
• Exposure to EU Clinical Trial Regulation (CTR) is a plus
• Procurement background is not aligned with this role