This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH / GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs 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.
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 closeout. Oversees FCPA, DPS / OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr. COM / 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.
* Collaborates closely with Headquarter to align country timelines for assigned protocols.
* 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.
* 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.
Your profile :
* 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
* Excellent verbal and written influencing and training / mentoring skills, in local language and English.
* Requires strong understanding of local regulatory environment
* Ability to lead a team of CTCs as applicable
* High sense of accountability and urgency in order to properly prioritize deliverables
* Strong communication, leadership, and negotiation skills as well as excellent influencing and training / mentoring skills, both written and verbal, in local language and English.
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