Clinical Operations Lead

IQVIA LLC; Reading; On-site; GBP 70,000 - 100,000; Full time

Job summary

IQVIA is recruiting for a Clinical Operations Lead to support sponsor-dedicated Clinical FSP activities and manage trial timelines, vendor relationships, and site coordination.

Minimum 3 years in biopharmaceutical/clinical research, 1+ year in clinical project management, and strong oncology experience are required. A science-focused degree and excellent communication are essential for success at IQVIA.

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.

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.

Skills

Clinical project management

Oncology

Vendor management

ICH-GCP knowledge

Multinational trials

Science degree

Strong communication

Biopharmaceutical industry experience

Education

Bachelor’s Degree in Science

Job description

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.

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 intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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.