Are you an experienced Clinical Research Associate and SSU Specialist with combined experience in Clinical Research and Finance/Business and are looking for your next career step?
Then this COM position, sponsor dedicated, at Covance can be perfect for you!
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
In this position you would:
- Have ownership of country and site budgets. Develop, negotiate, and complete Clinical Trial Research Agreements (CTRA).
- Oversee and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversee FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
- Execute and oversee clinical trial country submissions and approvals for assigned protocols.
- Develop local language materials including local language Informed Consent and translations. Interact with IRB/IEC and Regulatory Authority for assigned protocols.
- Manage country deliverables, timelines and results for assigned protocols to meet country commitments. You would be responsible for quality and compliance in assigned protocols in country.
- Contribute to the development of local SOPs. Oversees CTCs as applicable.
- Coordinate and liaise with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborate closely with Headquarter to align country timelines for assigned protocols.
- Provide support and oversight to local vendors as applicable.
- Oversee and coordinate 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.
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience;
- Excellent English, French and Dutch skills;
- Min 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business;
If you would like to learn more:
📞 +31 (0) 61 293 9571