For one of our clients, we are urgently looking for a junior project manager start-up.
Are you a CRA ready for a new step in your career? Then don't hesitate to get in touch!
As junior project manager start-up you will have a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. You must be able to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the Sr. Clinical Operations Manager.
You will have the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. As junior project manager you are accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP, country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Ownership of country and site budgets.
• Development, negotiation and completion of Clinical Trail Research Agreements (CTRA).
• Successful delivery of clinical and financial contracts within fair market value.
• Oversight and tracking of clinical research-related payments.
• Payment reconciliation at study close-out
• Oversight of Foreign Corrupcy Practices Act (FCPA), Denied Parties Screening and maintenance of financial systems.
Country submissions & Local Language Materials
• Oversees clinical trial country submissions and approvals for assigned protocols
• Develops local language materials (including local language Informed Consents and translations).
Management & Quality Oversight
• Manages deliverables, timelines and results for assigned protocols to meet commitments
• Responsible for quality and compliance in assigned protocols in the country.
• Contributes to the development of local SOPs.
• May oversee contract workers (CTCs) and local vendors as applicable
Local Process Oversight
• Enters and updates country information in clinical, regulatory, safety and finance systems
• Bachelor’s Degree in Life Science or equivalent Health Care degree.
• 5-7 years’ clinical research experience.
• Fluency in English, French and/or Dutch.
• Experience in clinical project management and coordination is an asset
• Expertise of core clinical, regulatory and financial systems, tools and metrics.
• Extensive knowledge of Belgian regulatory environment and submission and approval processes.
• Strong communication and leadership skills.
• Strong negotiation skills as well as excellent influencing and training/mentoring skills.
• The ability to focus on multiple deliverables and protocols simultaneously is essential.
• Ability to work effectively also in a remote virtual environment with a wide range of people.
• Strong coordination and organizational skills.
• Strong analytical and problem solving skills.
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