Clinical Study Manager
About the role
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As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of Senior Clinical Trial Manager the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.
Responsibilities include, but are not limited to:
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Financial forecasting
- Develops local language materials including local language Informed Consents and translations. Interacts with Ethics Committee 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 (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- 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.
- Ownership of local regulatory and financial compliance.
- Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- Experience in Submission Specialist role, with knowledge/experience of contract and budget negotiation
Why you are a good fit for this role:
- You are a strong communicator, have strong leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in Dutch and English.
- You are problem-solver, independant worker and like the dynamics of start-up!
- Rewarding career in clinical research: various kind of development opportunities: whether you want to further develop within your role, develop towards a different role or upwards, ICON is able to support you with dedicated line managers, training programs and a variety of clients!
- Competitive salary packages with extra advantages. Company car (with fuel card) or car allowance
- 80 to 100% working time
- Work-Life balance
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
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