Clinical Project Manager, Global

Overview

We currently have an exciting new opportunity for an experienced Global Clinical Project Manager to join a successful sponsor dedicated program. We are looking for a Global Clinical Project Manager which is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies.

The Global Clinical Project Manager is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. The Global Clinical Project Manager is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The Global Clinical Project Manager is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and / or external partners. The Global Clinical Project Manager leads the study team and / or study oversight team in accordance with the study team operating model, current clinical trial regulations (e.g. ICH GCP).

This is a permanent role with ICON on FSP and fully home-based. You must be located in the following countries to be considered : Bulgaria, UK, Poland OR Spain.

Responsibilities

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and / or oversight of several studies.
• Lead and facilitate communication across all functions, including external partners and service providers.
• Lead and conduct investigator meetings and other study related meetings. Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
• Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines / budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team.
• Accountable for ensuring that information in all systems utilized at a study-level (e.g. ACCORD / ABACUS, PharmaCM, etc.) are current and accurate.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and communicate any risks to timelines and / or quality to CPT and sDSM / DSM along with proposed mitigations.
• Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.).
• Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times.
• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency).
• The Global Clinical Project Manager is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process).

Qualifications

You must have current experience working in the clinical research industry within a Pharma or CRO setting within Global study delivery.

You must have the right to work with no sponsorship requirements in the following countries : Spain, UK, Poland and Bulgaria.

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