About this role
Start Up Lead
Location
Madrid
Reference: JR161582
vacancyopjusttionswidget.opt-Business Area
ICON Strategic Solutions (FSP)
Categories Clinical Trial Management
Remote Working Remote
About the role
Start Up Lead Home based Madrid
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.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
What You Will Do:
Key responsibilities include:
- Ownership of country and site budgets. Development, negotiation and completion of ClinicalTrial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /CRDs, other roles.
- 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 CTM, CTA, CRA, (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. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
- Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines.
- 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 the 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 the team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
Your Profile:
5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
Required qualifications and experience:
- Expertise of core clinical systems, tools and metrics
- Excellent verbal and written influencing and training/mentoring skills, in local language and English
- Strong coordination and organizational skills
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the manager.
- Ability to make decisions independently with limited oversight from the manager.
- Requires strong understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
- 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.
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.
Are you a current ICON Employee? Please click here to apply
Location
Madrid
Reference: JR161582
vacancyopjusttionswidget.opt-Business Area
ICON Strategic Solutions (FSP)
Categories Clinical Trial Management
Remote Working
Remote
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