AbbVie

Global biopharmaceutical company developing medicines

Clinical Operations Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeShanghai, ChinaNo salary listedRemote

About the Job

Requirements

Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or a four-year life science degree.
A minimum of 5 years of monitoring experience in a pharmaceutical or medical device company or clinical research organization.
More than 5 years of industry experience.
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft OneNote.
Written and oral communication skills.
Planning, organizing, and metrics-tracking skills.
Ability to control, direct, and promote innovation.
Decision-making, judgment, and problem-solving skills.
People relationship, influencing, motivating, team-building, and people-development skills.
Initiative and accountability.
Ability to assign, review, and plan other people's work.
Ability to maintain and coordinate activities.
Ability to train RSMs on trial specifics.

Responsibilities

Manage day-to-day monitoring activities on assigned studies to ensure deliverables are met by tracking and maintaining project metrics and deliverable status.
Proactively communicate and escalate issues, risks, and staffing needs to the Program Lead, RSMs, and Clinical Trial Team.
Serve as a resource for RSMs by answering study questions and providing guidance as an expert in standard study processes.
Review completed Site Feasibility Questionnaires and Site Qualification Visit reports, and maintain tracking reports (SIV, IMV, RMV, COV) for assigned trials.
Develop monitoring documents and toolkits for trials to ensure consistency, including Protocol Specific Monitoring Plans and amendments, report annotations, visit checklists, and toolkits.
Provide Protocol Specific Monitoring Plan training and assist with conducting GSMO orientation sessions as needed.
Conduct teleconferences with RSMs to deliver training and information as required.
Attend team meetings and disseminate information as necessary.
Collaborate with the Clinical Trial Team and GSMO PL to review study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing.
Serve as a Risk Based Monitoring ambassador, ensuring implementation and adherence to Risk Based Monitoring requirements on trials.
Maintain the monitoring portion of the study portal.
Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and the therapeutic area, including protocols and amendments.
Provide site presence, which may include monitoring one site on an assigned trial or conducting co-monitoring and oversight visits.
For Principal LSM duties, mentor new LSMs, assist with LSM orientation training, and contribute to process development, improvement, and documents that drive consistency.

Desired Qualifications

Experience functioning as a lead monitor or equivalent experience is preferred.

Job Description

Manage day-to-day monitoring activities on assigned study to ensure deliverables are met by tracking and maintaining project metrics and status of deliverables. Proactively communicate and escalate issues, risks and staffing needs to Program Lead, RSMs and Clinical Trial Team.
Act as a resource for RSMs to answer study questions and provide guidance as Allergan standard study process experts.
Review completed Site Feasibility Questionnaires, Site Qualification Visit reports and maintains all tracking reports (SIV, IMV, RMV, COV) for assigned trial.
Develop monitoring documents and toolkits for trial to ensure consistency such as Protocol Specific Monitoring Plan and amendments, report annotation, visit checklists, tool kits, etc. Provide PSMP training and assist with conducting GSMO orientation sessions as necessary.
Conduct with RSM teleconferences to deliver training and information as required. Attend team meetings and disseminate information as necessary.
Collaborate with CTT and GSMO PL in review of study specific eCRFs, completion guidelines, protocol deviation specifications, user acceptance testing, etc.
Serve as Risk Based Monitoring (RBM) ambassador ensuring implementation and adherence to RBM requirements on trial.
Maintain monitoring portion of study portal.
Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, therapeutic area (protocol, amendments).
Site presence (may be responsible for monitoring 1 sites on assigned trial or co-monitoring/oversight visits, etc.)
Principal LSM additional tasks: mentoring new LSMs, assisting with LSM orientation training sessions, contribute to process development, improvement and documents to drive consistency. Principal LSMs will typically be assigned to more complex therapeutic areas.

Qualifications

Qualifications

Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree.
Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization.
More than 5 year of industry experience.
Prefer candidates that have functioned as a lead monitor/ have equivalent experience.

Skills

Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote

Must possess excellent skill/ability in the following:

Written and oral communication
Planning, Organizing, Metrics Tracking
Controlling, Directing, and Promoting Innovation
Decision Making, Judgment, and Problem Solving
People Relationships, Influencing Others, Motivating Employees, Team Building, Developing People
Initiative and Accountability
Assigning work, reviewing work, and Planning other’s work
Maintaining activities and Coordinating activities
Training RSMs on trial specifics

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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