Global Trial Delivery Lead - Sponsor Dedicated
217 800 - 404 600 PLN/ rok.Umowa o pracę (brutto)
245 200 - 521 000 PLN/ rok.Umowa o pracę (brutto)
SeniorFull-time·Umowa o pracę
#344600·Dodano 13 dni temu·0
Źródło: IQVIATech Stack / Keywords
clinical trial managementICH-GCPTrial Master FileClinical Trial Management SystemsMicrosoft applicationsbudget managementrisk mitigationproject 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.
Wymagania
- Bachelor’s degree (BS) or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- 6–8 years of clinical trial management experience within the pharmaceutical industry or a CRO, including specific therapeutic area experience.
- Proven experience managing clinical trials end to end, from start-up through database lock and trial close-out.
- Strong working knowledge of ICH-GCP, local laws, and regulatory requirements.
- Superior clinical research operational knowledge with a demonstrated track record of delivery.
- Ability to ensure ongoing quality, compliance, and inspection readiness.
- Demonstrated effective leadership, with the ability to proactively guide study teams through key trial stages.
- Proven ability to delegate effectively while maintaining accountability.
- Experience leading teams from formation to high-performance.
- Strong capability to manage multiple global stakeholders and cross-functional partners.
- Proven experience coordinating global or regional teams in a virtual environment for a minimum of 2 years (preferably 3+).
- Ability to foster team productivity, alignment, and cohesiveness across geographies.
- Strong project planning and project management capabilities.
- Proven experience in proactive planning, risk identification, and mitigation throughout the trial lifecycle.
- Ability to gain team consensus on updated plans during changing project circumstances.
- Demonstrated capacity for independent, complex decision making.
- Solution-oriented mindset with strong problem-solving skills.
- Strong IT skills, including proficiency with Microsoft applications and familiarity with Trial Master File (TMF) & Clinical Trial Management Systems (CTMS).
- Willingness and ability to learn new systems and technologies.
- Monitoring experience is recommended; other relevant experience (e.g., data management or central monitoring) will be considered.
- Excellent verbal and written communication skills, supporting effective collaboration.
- Proven experience developing presentations and presenting complex information to stakeholders.
- Strong analytical skills, with the ability to manage ambiguity when limited information is available.
- Ability to understand, plan, and oversee country- and vendor-level budgets.
- Awareness of country Out-of-Pocket (OOP) cost drivers and FTE-related cost components.
- Willingness to travel as required.
- Proficiency in English (spoken and written) and the local country language, as applicable.
Obowiązki
- Serve as the single point of accountability for trial operational strategy, trial-level budget, quality, and on-time delivery of assigned clinical trials.
- Co-lead the Cross-Functional Trial Team (CFTT) to ensure trial strategies are aligned with program objectives and executed efficiently.
- Develop the trial operational strategy, integrating and aligning all trial-level functional strategies into a single, holistic approach, including vendor strategy.
- Partner closely with the Program Delivery Leader (PDL) to shape trial-level strategy in alignment with overall program strategy.
- Set meeting cadence, agendas, and expectations for the CFTT.
- Empower CFTT members to independently drive their functional deliverables while maintaining accountability for timelines and quality.
- Ensure all trial milestones, quality targets, and budget commitments are met.
- Provide budget management and oversight at the trial level, including scenario planning and cost optimization.
- Review and approve key study-level documents (e.g., global master ICFs).
- Proactively identify, assess, and mitigate trial-level risks, overseeing them through to closure.
- Define protocol deviation and resolution pathways.
- Take ownership of study-level escalations, including vendor performance issues and enrollment risks.
- Communicate trial risks, issues, changes, and milestones to relevant stakeholders in a timely and transparent manner.
- Represent Global Development (GD) at trial-level therapeutic area (TA) governance forums.
- Contribute to and influence governance decisions, ensuring operational feasibility and alignment.
- Attend Clinical Team (CT) meetings when requested by the PDL.
- Ensure strong alignment with key stakeholders on protocol amendments, enrollment targets, and study changes.
- Ensure all trial operational activities, TMF, and study documentation are health authority–compliant, inspection-ready, and meet required quality standards at all times.
- Set up and oversee clinical trial systems and documentation, including E7 drivers, Safety Management Plan, JJAR & Unified Clinical Trial Team (UCT) setup.
Oferta
- Potential base pay range when annualized: 217,800.00 - 521,000.00 PLN.
- Incentive plans, bonuses, and/or other forms of compensation may be offered.
- Range of health and welfare and/or other benefits may be offered.
Inne informacje
Due to sponsor requirements for the role, only candidates based in the listed location(s) (Warsaw, Poland) will be considered. Applications from candidates based outside of these locations will not be considered.
IQVIA maintains a zero tolerance policy for candidate fraud. False statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification or termination of employment if discovered later, in accordance with applicable law.
IQVIA
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