AbbVie

Global biopharmaceutical company developing medicines

Associate Study Management 3

Clinical Research OperationsPosted on Nov 9

Full-timeShanghai, ChinaNo salary listedRemote

About the Job

Requirements

A bachelor's degree or OUS equivalent is required.
At least 4 years of progressive pharma-related or clinical research-related experience, with a high level of core and technical competencies, is required.
Competence in applying standard quality procedures, including SOPs, ICH/GCP, and global regulations, is required.
Experience using systems such as EDC, IRT, CTMS, and eTMF is required.
Strong analytical and critical-thinking skills are required to evaluate complex issues from multiple perspectives, develop strategies, and support decision-making to accelerate study timelines and enable a well-run study.
Strong organizational and time-management skills and attention to detail are required.
Interpersonal skills and the ability to communicate clearly and persuasively in a global setting are required.
Proficiency in spoken and written business/technical English is required.
A proactive and collaborative mindset and the ability to work independently in a fast-paced global team environment are required.

Responsibilities

Lead and contribute independently to clinical studies with appropriate support from the Study Project Manager, while complying with quality standards, ICH/GCP, global regulations, and company policies and procedures.
Provide study-level oversight and leadership for one or more global trials from inception through closure, connecting functional and strategic work across each study.
Support the Study Project Manager in strategic leadership of cross-functional teams through stakeholder engagement and influence, strategy development, meeting facilitation, and timely study-level documentation to drive deliverables, timelines, and clinical trial execution.
Manage vendors, including requests for proposal and initiation, selection, scope-of-work development and review, deliverable oversight, and risk management for external vendors such as central laboratories, recruitment, imaging, and internal and external committees.
Manage global recruitment by reviewing intelligence data, providing leadership, developing and executing cross-functional recruitment strategies, and planning mitigations from country feasibility through subject recruitment and retention.
Lead cross-functional, vendor, and/or investigator meetings; provide regular study-status updates; develop agendas; curate and file minutes.
Ensure inspection readiness and participate in related activities. Identify, mitigate, and manage risks, including timely issue review, escalation, and management to support trend analysis and risk prevention.
Co-develop and manage study materials through review, revision, tracking, and filing, including protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent, site budgets and agreements, clinical study reports, training materials, newsletters, and stakeholder presentations.
Manage CTMS and eTMF to ensure compliance and inspection readiness, support trend analyses, and support timelines.
Review EDC, IRT, and ePRO design specifications; participate in user acceptance testing; contribute to related plans and key risk indicators; and support system management activities such as access support, query resolution, and oversight.
Manage investigational product and other associated study supplies.
Provide engaging training to identified stakeholders, including study team members and vendors, as needed.
Support global submission strategies.
Support process-improvement initiatives or serve as a subject-matter expert and/or mentor.

Desired Qualifications

Exposure to study initiation-through-completion activities is preferred.
Global study exposure is preferred.

Job Description

The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
o Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
o Vendor management, including Request for Proposal (RFP)/initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
o Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
o Leadership of assigned meetings (cross-functional (internal), vendor, and/or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing. o Ensure inspection readiness and participate in related activities. Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to:
o Protocols, regulatory submissions, patient reported outcome measures, study execution plan, informed consent, site budgets and agreements, clinical study report, training materials, newsletters, presentations for various stakeholders
o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
o EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight. Management of investigational product and other associated study supplies.
Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors. Support global submission strategies. Support process improvement initiatives or serve as a subject matter expert and/or mentor

Qualifications

Bachelor’s Degree or OUS equivalent required
Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
Experienced user of systems such as EDC, IRT, CTMS, and eTMF
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.
Excellent organizational and time management skills, strong attention to detail.
Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
Proactive, collaborative mindset
Ability to work independently in a fast-paced global team environment
Preferred: Exposure to study initiation through completion activities; global study exposure

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

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