
10,000+ employees
Founded 2013
đ„ Healthcare
đŒ Consulting
đ Manufacturing
Healthcare âą Consulting âą Manufacturing
AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.
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10,000+ employees
Founded 2013
đ„ Healthcare
đŒ Consulting
đ Manufacturing
Healthcare âą Consulting âą Manufacturing
AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.
âą Advance AbbVie's clinical research pipeline by striving for excellence in clinical research âą Partner with study teams, internal R&D stakeholders, investigators and site staff âą Serve as the primary Sponsor point of contact for the investigative site âą Provide contextual clinical-trial information and connect stakeholders with investigative sites âą Motivate and align the monitoring community through leadership and mentorship âą Train and motivate site staff and principal investigators on trial goals, protocol and patient-treatment principles âą Support, guide and mentor junior personnel on Site Management activities âą Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring âą Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards âą Customize site-engagement strategies and track progress and impact using site-engagement tools âą Apply scientific principles and clinical-trial requirements to day-to-day trial execution âą Generate and ensure effective patient recruitment and retention techniques and plans âą Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge âą Mentor and train less experienced CRAs and support local onboarding âą Participate in or lead global/local task forces and initiatives âą Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues âą Resolve site-risk signals and implement preventative and corrective action plans âą Identify, evaluate and recommend investigators and sites for clinical studies âą Ensure data quality and timely submission, including safety-event reporting and follow-up âą Maintain audit and regulatory inspection readiness at assigned clinical sites âą Manage investigator payments according to executed contract obligations, as applicable
âą Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred âą Minimum of 3 years of clinically related experience âą Preferably 2 years in independent clinical research monitoring of investigational drug or device trials âą Familiarity with risk-based monitoring approach, onsite and offsite monitoring âą Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials âą Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies âą Advanced communication and cross-functional collaboration skills âą Superior planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines âą Ability to leverage technology, tools and resources for customer-centric site support âą Superior interpersonal, written, verbal, active listening and presentation skills âą Ability to independently use functional expertise, critical thinking and good judgement to address clinical site issues âą Integrity in accordance with AbbVie code of business conduct and leadership values âą Self-motivated and focused on timely, quality outcomes âą Excellent command of English and local language
âą Employees can work remotely âą Equal opportunity employer âą Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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