Clinical Operations Lead

IQVIA; Lisboa; Presencial; EUR 70 000 - 100 000; Tempo integral

Resumo da oferta

IQVIA seeks a Clinical Operations Lead in Lisbon to support trial execution across therapeutic areas. You will liaise with project teams, CROs, and vendors to ensure adherence to study timelines and quality standards.

The role emphasizes development of trial documents, feasibility input, and management of timelines, IP strategy, and vendor performance, in a fast-paced environment.

Qualificações

• Minimum 3 years’ experience in biopharmaceuticals or relevant clinical research.
• Minimum 1 year in Clinical Project Management.
• Oncology therapeutic area knowledge.
• Experience in multinational/global clinical trials.
• Strong vendor management experience.
• Working knowledge of ICH GCP and regulatory requirements.
• Ability to manage multiple priorities across protocols.
• Strong communication with teams, sites, and vendors.

Responsabilidades

• Review, develop, and write clinical trial documents and manuals (e.g., study manuals, biomarker plans).
• Create and review Master ICF templates; update for risks and amendments.
• Participate in site feasibility and evaluation.
• Help manage study timelines and recruitment strategies.
• Plan and organize investigator/coordinator meetings.
• Assist in IP and co-medication strategy development.
• Monitor timelines and vendor deliverables (Monitoring, IVRS, labs).
• Build relationships with sites and institutions to enhance trial conduct.

Conhecimentos

Clinical Project Management

Vendor Management

ICH GCP Knowledge

Communication Skills

Prior multinational trials

Formação académica

Bachelor's Degree in Science

Ferramentas

IVRS

Descrição da oferta de emprego

Reading, Berkshire, United Kingdom

Zagreb, Croatia

Lisbon, Portugal

Barcelona, Spain

Prague, Czech Republic

Madrid, Spain

Full time

R1566767

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

The Clinical Operations Lead supports the Clinical Trial Operational team in execution of the trials. The position maintains effective communication with project team through correspondence and status reports to ensure alignment with study timelines. The COL includes direct liaison with CROs and other vendors to manage relevant trial operational lasts.

Main Responsibilities

• Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans.
• Create Master ICF template and review site changes. Update template for new risks and new amendments information.
• Participate in the feasibility and evaluation of investigative sites.
• Assist in the development and management of study timelines and priorities, including recruitment tools/ strategy and patient retentions plan.
• Plan and organize meetings with team support (eg. investigator/ coordinator meetings).
• Assist in the development of the IP and co-medication strategy.
• Monitor study specific timelines and key deliverables; focus on management of vendors (eg. Monitoring, Sample management, IVRS, Laboratory).
• Develop relationships with investigational sites and institutions to enhance conduct of the trial.
• Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

Required Skills and Qualifications

• Minimum of 3 years’ experience in the biopharmaceutical industry or other relevant clinical research experience.
• Minimum 1 year or experience in Clinical Project Management.
• Proven work experience and knowledge of Oncology therapeutic area.
• Bachelor’s Degree or relevant degree with strong emphasis on Science.
• Prior experience in assisting the conduct and management of multinational/ global clinical trials.
• Strong experience in vendor management.
• Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Strong communication skills with internal teams, sites, and vendors.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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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