IQVIA

Global Senior Trial Delivery Manager - Sponsor Dedicated

217.8k - 404.6k PLN217 800 - 404 600 PLN/ rok./ rok.UoPUmowa o pracę (brutto)

SeniorOn-site·WarszawaFull-time·Umowa o pracę

#344591·Dodano 6 miesięcy temu·7

Źródło: IQVIA

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Tech Stack / Keywords

ICH-GCPTrial Master FileClinical Trial Management SystemMicrosoft OfficeCAPAClinical TrialVendor ManagementBudgetingRisk MitigationData Management

Firma i stanowisko

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The role involves global coordination of clinical trial management activities for internally managed and/or outsourced trials, supporting the Global Clinical Development Operations Trial Leader and leading the Study Management Team.

Wymagania

BS degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
6-8 years clinical trial management experience in pharmaceutical industry or CRO.
Specific therapeutic area experience.
Strong working knowledge of ICH-GCP, local laws, and regulations.
Proven track record managing trials from start-up to database lock and closure.
Effective leadership and delegation skills.
Ability to manage multiple stakeholders and lead high performing teams.
Experience coordinating global or regional teams in virtual environments for at least 2-3 years.
Proactive planning, risk mitigation, and team consensus building skills.
Strong project planning and management skills.
Independent complex decision making.
Solution oriented with proactive risk identification and mitigation.
Strong IT skills including Microsoft applications, Trial Master File, Clinical Trial Management System.
Monitoring experience recommended or relevant experience such as data management or central monitoring.
Willingness to travel.
Proficient in local country language and English, both spoken and written.
Strong verbal and written communication skills.
Strong analytical skills and ability to manage ambiguity.
Experience developing presentations and presenting to stakeholders.
Ability to plan and oversee country and vendor budgeting processes.

Obowiązki

Lead the Study Management Team and provide updates on deliverable status.
Ensure availability of reports to support real-time tracking of trial status.
Manage timely and accurate documentation and communication of trial progress.
Ensure the Study Management Team operates in a constant state of inspection-readiness.
Act as primary contact for Country and Regional staff and local teams within GCDO.
Partner with the Global Trial Lead to execute and oversee central activities from planning through trial close-out.
Ensure issue escalation and drive issue resolution.
Work closely with Trial Team to ensure CAPAs are resolved timely.
Contribute to data collection to support site selection and participate in feasibility.
Establish enrollment commitments and ensure actual enrollment meets projections.
Ensure robust recruitment/contingency plans are in place for each region.
Perform Annual Quality Review of files and ensure archiving and retention of documents.
Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses.
Oversee selected vendors and status of related deliverables.
Review and approve assigned vendor invoices/spend.
Monitor budgets and expenditures per planned trial budget.
Create and update trial-specific documents including Monitoring Guidelines, Informed Consent Form, IMP documentation, Blinding Plan, and feasibility documents.
Provide input into cross-functional documents such as safety documents, protocol deviations, and issue escalation processes.
Provide central documents required for HA/EC/IRB submission.
Ensure creation and delivery of appropriate trial-specific training materials.
Responsible for set-up, coordination, and participation of Investigator Meetings.
Establish and maintain excellent working relationships with internal stakeholders.
Ensure compliance with Health Authority regulations, SOPs, and GCP.
Participate in preparation for and conduct of Health Authority inspections and internal audits.
Work with Bioresearch Quality & Compliance liaisons to ensure quality oversight.
Coordinate data cleaning towards timely and successful database lock.
Act as central expert for assigned protocol(s).
Contribute to process improvement and training as applicable.

Benefity

Potential base pay range when annualized: 217,800.00 - 404,600.00 PLN.
Incentive plans, bonuses, and/or other forms of compensation may be offered.
Range of health and welfare and/or other benefits may be provided.

Inne informacje

IQVIA maintains a zero tolerance policy for candidate fraud. All information and credentials submitted must be truthful and complete. False statements, misrepresentations, or material omissions during recruitment will result in disqualification or termination in accordance with applicable law.

Position is Poland exclusive.

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