Global Clinical Site Management Lead

BioSpace; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

PTO

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie is seeking a Senior Manager, Clinical Site Management to provide direction and operational expertise for CSM integrity, quality, and timeliness in assigned studies. Will serve as study strategy leader or manage area site execution with cross-functional collaboration globally.

The role drives site monitoring strategy, engagement, protocol adherence, and close-out while ensuring readiness for inspections and TMF completeness.

Qualifications

• Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• A minimum of 5 years+ of industry clinical research experience including 2 years of monitoring or project management on a global study.
• Preferred exposure in study initiation through study completion in multiple phases (Phase II/III, Phase I in patients).
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
• Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
• Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
• Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills for a fast-paced environment.
• Able to work well within a team and autonomously. Thinks proactively. Strong ability to create and deliver presentations.
• Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote

Responsibilities

• Drive study-level global and/or area-level CSM deliverables by timelines with allocated resources.
• Analyze study timelines and assumptions to confirm deliverables for CSM. Communicate resource needs with Country Leaders.
• Ensure study-level/area-level timelines are maintained across lifecycle and drive site-level activities.
• Oversee monitoring activities at study/area level, ensure quality deliverables and milestone adherence.
• Identify, evaluate, and mitigate risks; contribute to RAMP.
• Collaborate with other SMLs and stakeholders to manage risks and align study execution.
• Provide inputs on CSM documents at study level and drive TMF completeness for CSM artifacts.
• From study start to close ensure ongoing CSM inspection readiness activities.

Skills

Communication skills

Leadership

Project management

Team collaboration

Presentation skills

Education

Bachelor's Degree in a para/medical or scientific field

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft OneNote

Job description

AbbVie is seeking a Senior Manager, Clinical Site Management to provide direction and operational expertise for CSM integrity, quality, and timeliness in assigned studies. Will serve as study strategy leader or manage area site execution with cross-functional collaboration globally.

The role drives site monitoring strategy, engagement, protocol adherence, and close-out while ensuring readiness for inspections and TMF completeness.