Global Senior Trial Delivery Manager - Sponsor Dedicated

IQVIA; Paris; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

IQVIA in Paris is seeking a Senior Clinical Trial Manager to lead the Study Management Team, oversee trial planning from start-up through close-out, and ensure real-time reporting and inspection readiness.

You will coordinate with country and regional staff, manage budgets and vendor activities, and drive CAPAs and risk mitigation in a global, virtual environment. Travel is required and effective cross-functional communication is essential.

Qualifications

• BS degree or equivalent in Life Sciences.
• 6-8 years clinical trial management experience in pharma/CRO.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Proven leadership to drive Study Management Team through trial stages.
• Experience coordinating global/regional teams in virtual environments.
• Proficient in English and local language.

Responsabilités

• Lead the Study Management Team, providing updates on deliverable status.
• Ensure real-time trial status reporting and inspection readiness.
• Manage documentation and communication of trial progress.
• Coordinate with country/regional staff and Global Trial Lead.
• Oversee CAPAs and issue resolution; drive risk mitigation.
• Support site selection, feasibility, and enrollment planning.
• Oversee budgets, vendor selection, invoices, and spend.
• Develop and maintain trial-specific training materials and records.

Connaissances

Leadership

CDM coordination

Budgeting

ICH-GCP knowledge

Vendor management

Communication

Formation

BS degree in Life Sciences

Outils

Trial Master File

CTMS

Description du poste

Reading, Berkshire, United Kingdom

Paris, France

Prague, Czech Republic

Sofia, Bulgaria

Madrid, Spain

Milan, Italy

Full time

Task:

• Services rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• Complies with relevant training requirements.
• Lead the Study Management Team including providing updates to all trial team members on deliverable status.
• Ensure availability of required reports to support real time tracking of trial status according to trial plan.
• Manage timely and accurate documentation and communication of trial progress.
• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Act as the primary contact person for the local teams within GCDO.
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
• Ensure issue escalation and drive issue resolution.
• Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
• Contribute to data collection to support the site selection process.
• Participate in feasibility, providing recommendations as needed.
• Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
• Ensure the availability of robust recruitment/contingency plans are in place for each region.
• Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
• Perform Annual Quality Review of files, as appropriate.
• Ensure archiving and retention of documents per set requirements.
• Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses.
• Oversight of selected vendors and status of related deliverables.
• Review and approve assigned vendor invoices/spend.
• Monitor budgets and expenditures as expected per planned trial budget.
• Create and update trial-specific documents as required, including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
• Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
• Provide central documents required for HA/EC/IRB submission.
• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
• Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
• Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
• Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Coordinate data cleaning with some supervision towards a timely and successful database lock.
• Act as central expert for assigned protocol(s).
• Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
• Contribute to process improvement and training, as applicable.

Requirements:

• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
• Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
• Effective leadership skills and ability to manage multiple stakeholders.
• Proven ability to lead a team through formation stages, up to operating as a high performing team.
• Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
• Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
• Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
• Strong project planning/management.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.
• Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
• Travel.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills leading to successful team collaboration
• Strong decision making. Solution oriented.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Experience in developing presentations and presenting key information to stakeholders.
• Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.
• Please note This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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