Clinical Trial Manager

Pharmaceutical Research Associates, Inc; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

Join an innovative and dynamic clinical research organization as a Clinical Operations Lead. In this pivotal role, you will support the execution of clinical trials within a growing Biotech specializing in Oncology. Your expertise will help in developing clinical trial documents, managing study timelines, and ensuring compliance with regulatory standards. This position offers a unique opportunity to enhance your career while contributing to life-changing research. Enjoy a competitive salary and a range of benefits designed to support your well-being and work-life balance in a collaborative environment that values diversity and inclusion.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• Minimum of three years in biopharmaceutical or clinical research.
• Strong emphasis on science with recent Trial Management experience.

Responsibilities

• Support Clinical Trial Manager in executing trials and managing timelines.
• Coordinate activities at investigational sites and monitor deliverables.

Skills

Trial Management

Clinical Research

ICH Good Clinical Practices

Multinational Clinical Trials

Project Management

Education

BS/BA degree in Science

Job description

Overview

Title - Clinical Operations Lead

Location - EMEA, remote

Sponsor dedicated

As a Clinical Operations Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

Working fully embedded within a growing Biotech that specializes in the Oncology space, you will support the Clinical Trial Manager/operational team in execution of the trials.

What you will be doing:

1. Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
2. Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
3. Participate in the feasibility and evaluation of investigative sites; working closely with the Clinical Trial Logistics group.
4. Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
5. Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retention plan.
6. Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.).
7. Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
8. Participate in data review and discrepancy resolution.
9. Participate in coordinating efforts with internal Pharmacovigilance, and safety group.
10. Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc.).
11. Participate as a member of the multi-disciplinary trial(s) team.
12. Develop relationships with investigational sites and institutions to enhance conduct of the trial.
13. Act as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
14. Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effectiveness and quality of the functioning of the Development Operations Department.

Qualifications

You are:

• BS/BA degree or a relevant degree with strong emphasis on science.
• Must have recent Trial Management experience in a similar type of role.
• Minimum of three years of experience in the biopharmaceutical industry or other relevant clinical research experience.
• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Prior experience in assisting the conduct and management of multinational clinical trials.

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

For reasonable accommodations, please visit: https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.