Specialist, Country Study Start Up

hace 7 meses

Ciudad de México ABBVIE A tiempo completo

**Purpose**:The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.
- Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads_

**Primary responsibilities**:

- Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites
- Establish the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
- Proactively identify and communicate issues impacting delivery and providing proposed solutions.
- Attend regional/area start up calls and providing input for assigned sites/studies
- Collection of essential documents from sites and completing quality check (ALCOA)
- Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
- Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements
- Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation
- Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
- Trigger clinical supply shipments
- Complete IP release activities and triggering IP shipment
- Issue site green light letter and activating sites in IXRS
- Track all start up and maintenance related activities in Vault SSU as appropriate
- Maintain local country and site intelligence database and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies.
- Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
- Ensure audit/inspection readiness
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
- Participate in process improvement initiatives as required

**Qualifications**:

- Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
- Experience working with remote/virtual teams
- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
- Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
- Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment

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