Senior Specialist, Country Study Start Up

BioSpace; Shanghai (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Sr. Specialist, Country Start Up, to drive and execute country start-up and maintenance activities for assigned studies and sites. You will act as a subject-matter expert, mentoring specialists and ensuring on-time, high-quality delivery across complex protocols and multiple sites.

The role requires strong regulatory know-how, robust project coordination, and experience with Vault SSU. It offers growth in process improvements and cross-functional leadership within a global

Qualifications

• Minimum 3 years of clinical research experience and 2+ years in study start up management for designated region.
• Experience working with central and local IRB/EC sites and reviewing ICFs for approval.
• Familiarity with ICH and GCP guidelines and country regulatory environment.

Responsibilities

• Ensure on-time, quality execution of start-up and maintenance activities for sites and studies.
• Coordinate with Regulatory and CTS on submissions and approvals to align with activation timelines.
• Track start-up and maintenance activities and provide updates to leadership.

Skills

Clinical research

Project coordination

Regulatory knowledge

Analytical thinking

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Sr. Specialist, Country Study Start Up proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. The Sr. Specialist, Country SSU is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities. Acts as a site start up expert and provides SME support and mentoring of Specialists, Country Start Up by delivering training and change management in the adoption of new technologies and processes. Continuously supports Country CSM leadership (COM / Country Head) to identify and drive improvements in Country Start-up cycle times.

Responsibilities

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Advanced competency in establishing 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, and ability to work across multiple complex protocols and Sites. Proactively identifying and communicating issues impacting delivery and providing proposed solution
• Attend regional/area start up calls and provide input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA) Compile and submit ethics and other required local document packages 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. Lead Collaborations with contract manager, Site Monitor, Area CSM Lead regarding activation timelines to assure timely site activation. Review 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. Able to mentor junior personnel on 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. Support COM / CCOM to analyse and drive improvements in Country SSU performance metrics. Ensure audit/inspection readiness.
• Drive to improve site start up efficiency, which includes leading process improvement initiatives.
• Function as a SME in the SSU community and leads training and mentoring of Specialists, Country Start Up, drive change management in the adoption of new technologies and processes. May act as area lead for studies that only involve one country (i.e.: US only trials).
• Train and mentor Specialists, Country Start Up
• 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 3 years of clinical research experience and preferably 2+ years of study start up management experience for the designated region. Must have hands on experience in interpreting regional clinical research regulations and processes.
• Experience working with central and local IRB/EC sites, inclusive of reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
• Adept and experienced working with Vault SSU in the capacity of essential document processing, IP release, and ICF IRB/EC review. Experience working with remote/virtual teams.
• Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making.
• Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment.
• Demonstration of driving and leading successful initiatives, special projects and activities that support the business.
• Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html