Clinical Operations Lead

IQVIA; Oeiras; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence, supporting our client’s trials in multiple therapeutic areas. The Clinical Operations Lead role ensures alignment with study timelines and coordinates with CROs and vendors to manage trial operations.

The position focuses on reviewing trial documents, developing timelines, and maintaining relationships with sites.

Qualificações

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

Responsabilidades

• Assist in review, development and writing of clinical trial documents and manuals.
• Create Master ICF template and review site changes; update template for new risks and amendments.
• Participate in feasibility and evaluation of investigative sites.
• Develop and manage study timelines and priorities, including recruitment tools/strategy and patient retention plan.
• Plan and organize meetings with team support (e.g., investigator/coordinator meetings).
• Assist in IP and co-medication strategy development.
• Monitor study timelines and key deliverables; manage vendors (monitoring, sample management, IVRS, laboratory).
• Develop relationships with investigational sites to enhance trial conduct.
• Act as liaison for study sites to convey trial information and escalate as needed.

Conhecimentos

Biopharma experience

Clinical Project Management

Oncology knowledge

Multinational trials experience

Vendor management

ICH-GCP knowledge

Communications across teams

Formação académica

Bachelor's Degree in Science

Descrição da oferta de emprego

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.