AbbVie

Global biopharmaceutical company developing medicines

Senior Specialist - Country Study Start Up

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeShanghai, ChinaNo salary listedHybrid

About the Job

Requirements

A minimum of 3 years of clinical research experience is required, with preferably 2 or more years of study start-up management experience for the designated region.
Hands-on experience interpreting regional clinical research regulations and processes is required.
Experience working with central and local Institutional Review Board/Ethics Committee (IRB/EC) sites, including reviewing site or IRB/EC comments on Informed Consent Forms (ICFs) and routing them for approval by required functional areas, is required.
Experience working with Vault SSU in essential document processing, investigational product (IP) release, and ICF IRB/EC review is required.
Experience working with remote or virtual teams is required.
The role requires the ability to evaluate complex issues from multiple perspectives and make informed decisions.
The role requires the ability to manage multiple priorities in a fast-paced environment.
Working knowledge of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, and operational understanding of the country's regulatory environment, are required.

Responsibilities

Drive and execute start-up and maintenance activities and deliverables for assigned studies and sites in assigned countries, ensuring on-time, on-budget, quality delivery.
Establish country and site activation plans and priorities, including risk assessment and mitigation plans, in collaboration with CCOM/COM, Area SSU and CSM Lead, Contract Manager, and CTS/Regulatory Affairs; work across multiple complex protocols and sites; identify and communicate delivery issues and propose solutions.
Attend regional or area start-up calls and provide input for assigned sites and studies.
Collect essential documents from sites and perform quality checks using ALCOA principles; compile and submit ethics and other required local document packages, including customized ICFs, patient-facing materials, and safety reporting.
Coordinate with Regulatory and CTS on Clinical Assessment (CA) submission and approval status to align with other site activation requirements.
Collaborate with the Contract Manager, Site Monitor, and Area CSM Lead on activation timelines to ensure timely site activation; review site or IRB/EC comments on ICFs and route them for approval by required functional areas.
Trigger clinical supply shipments, complete IP release activities, trigger IP shipments, issue site green-light letters, activate sites in IXRS, and track start-up and maintenance activities in Vault SSU.
Maintain the local country and site intelligence database and EDLs in Vault; mentor junior personnel on Vault.
Maintain start-up performance metrics and key performance indicators (KPIs) for assigned sites and studies; provide updates and metrics to CCOM/COM and Area SSU and CSM Leads; support CCOM/COM in analyzing and improving Country SSU performance metrics.
Ensure audit and inspection readiness and compliance with corporate and divisional policies and procedures aligned with worldwide regulations and guidelines.
Drive site start-up efficiency, including leading process improvement initiatives; participate in process improvement initiatives as required.
Function as a subject-matter expert in the SSU community; lead training and mentoring of Specialists, Country Start Up, and drive change management in adopting new technologies and processes.
May act as area lead for studies involving only one country, such as US-only trials.
Train and mentor Specialists, Country Start Up.

Desired Qualifications

A Bachelor's degree in a health care or scientific field is highly preferred, or equivalent years of experience may be accepted.
Study start-up management experience of 2 or more years for the designated region is preferred.

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.
Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
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

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size: 10,001+
Company stage: IPO
Headquarters: North Chicago, IL
Founded: 1888

Recently Posted Jobs

Explore more opportunities at AbbVie

See more jobs