Clinical Trial Manager

ICON Strategic Solutions; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Annual leave entitlements

Résumé du poste

ICON Strategic Solutions, a sponsor-dedicated model provider, seeks a COM to lead local regulatory submissions and ICF customization for EU trials. You will collaborate with HQ and authorities to ensure timely approvals and contract delivery.

The role requires solid clinical trial management experience, advice on regulatory deliverables, and active interaction with IRB/IEC and authorities. Travel up to 25% is expected.

Qualifications

• University degree in medicine, science, or equivalent combination of education & experience.
• Demonstrated ability to drive the clinical deliverables of a study.
• Subject matter expertise in the designated therapeutic area.
• Willingness to travel as required (approximately 25%).

Responsabilités

• Oversees and tracks clinical research-related payments; oversight by finance but COM ensures compliance.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations.
• Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results to meet country commitments; ensures quality and compliance.
• Contributes to the development of local SOPs.
• Coordinates with study team members to obtain submissions, budgets, CTRAs and local milestones.
• Collaborates with Headquarter to align country timelines and provides vendor support as applicable.
• Oversees local processes, imports/exports, filing, archiving and retention; updates country information in systems.
• Ownership of local regulatory and financial compliance.

Connaissances

Clinical trial management

Regulatory affairs

Project leadership

Travel readiness

Formation

University degree in medicine, science, or equivalent combination of education & experience

Description du poste

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The COM role is equivalent to a local regulatory specialist position. The candidate must have experience in preparing initial submission packages and substantial amendments (EU-CTR Part II), including the customization of Informed Consent Forms (ICFs).

You Will Do

• Oversees and tracks clinical research-related payments. Payments are managed by finance specialist, but the COM needs to have an oversight on this activity
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Coordinates and liaises with study team members (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.
• Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Ownership of local regulatory and financial compliance..
• Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Contribute or lead initiatives and projects adding value to the business
• Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Your Profile

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.

Required Qualifications And Experience

• University degree in medicine, science, or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in the designated therapeutic area
• Prior monitoring experience is preferred
• Willingness to travel as required (approximately 25%)

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, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here