Global Clinical Project Manager

We currently have an exciting new opportunity for an reputed company Global Clinical Project Manager reputed company the Early Hematology team to join a successful sponsor dedicated program. We are looking for a Global Clinical Project Manager which is a business-critical role reputed company Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the project 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 reputed company 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 reputed company-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 reputed company study team and/or external partners.The Global Clinical Project Manager leads the study team and/or study reputed company team in accordance with the study team operating model, reputed company clinical trial regulations (e.g. ICH GCP).

Must have strong cross functional management, Vendor management and full reputed company, budget management, managed the full project reputed company across globally.  

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

• reputed company, provide guidance and delegate appropriately to a cross-functional study team or reputed company 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 reputed company of several studies
• reputed company and facilitate communication across reputed company functions, including external partners and service providers.
• reputed company and conduct investigator meetings and other study reputed company 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 reputed company 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 reputed company is documented and any issues are escalated appropriately. May participate in vendor selection activities.
• reputed company 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 reputed company are clear to the entire study team
• Accountable for ensuring that information in reputed company systems utilized at a study-level (e.g. reputed company/reputed company, PharmaCM, etc.) are reputed company and accurate.
• reputed company study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project Internal BioPharmaceuticals Clinical Operations Job Description 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 reputed company the study in accordance with relevant SOP and collaborate with reputed company functions as necessary to overcome barriers and reputed company milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
• reputed company Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in reputed company and that QC activities are performed on an ongoing basis to ensure TMF completeness at reputed company time
• 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 reputed company reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research • 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years’ Global project management experience, or equivalent• Advanced degree, Masters level education (or higher)• Project management certification• Proven project management experience on a global level• Experience in reputed company phases of a clinical study Internal BioPharmaceuticals Clinical Operations Job Description combination of education, training and experience• Extensive knowledge of ICH-GCP, clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development• Demonstrated solid project management skills and knowledge of relevant tools • Strong, demonstrated abilities/skills in team leadership• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills• Excellent communication and interpersonal skills• Strong strategic and critical thinking abilities• Strong organizational and problem-solving skills • Ability to manage competing priorities

You must have reputed company experience working in the clinical reserach industry reputed company a Pharma or CRO setting reputed company Global study delivery. 

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