Associate, Study Management II//CTM II

BioSpace; Shanghai (VA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

AbbVie is seeking a qualified professional to support clinical studies, ensuring adherence to ICH/GCP, global regulations, and AbbVie policies. You will help lead cross-functional study teams, maintain CTMS updates, and contribute to study blueprint and documentation efforts.

The role includes training materials development for sites and vendors, proactive issue resolution, and participation in process improvement initiatives.

Qualifications

• Bachelor’s degree required, typically in nursing or a scientific field.
• Registered Nurse licensure with appropriate degree is acceptable.
• Experience supporting clinical studies and cross-functional study teams is preferred.

Responsabilités

• Execute elements of clinical studies in compliance with ICH/GCP and AbbVie policies.
• Support Study Project Manager in leading cross-functional study team activities and updates.
• Assist in developing study blueprints, protocols, informed consent forms, eCRFs, IRT, and CSR.
• Support vendor selection, scope development, and oversight of external vendors.
• Generate training materials for study teams, sites, and vendors.
• Identify and escalate study-related issues and participate in process improvements.

Connaissances

Clinical study coordination

Cross-functional teamwork

Documentation

Quality compliance

Formation

Bachelor’s Degree in nursing or science

Outils

CTMS

eCRF systems

Description du poste

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

• Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• Supports the Study Project Manager in leading the cross functional study team: o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) o -Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
• Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR) Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
• Proactively identify and resolve and/or escalation study related issues
• Participates in process improvement initiatives

Qualifications

• Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.

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