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

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies. Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. If assigned as the study strategy leader, is a key member of the Clinical Study Team representing CSM globally from study planning to close out. If assigned to area site execution activities, responsible and accountable for directing site monitors in a matrix environment and serve as a liaison and primary contact between site monitors, the study strategy leader, and the Clinical Study Team.

Responsibilities

• Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
• Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM. Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones. Accountable for study level site monitoring strategy, documented in Site Monitoring Plan. Accountable to set and lead Site Engagement Strategy.
• Ensure study-level and/or area-level timelines are maintained across the study lifecycle. Provide timely and essential study information for country-level teams to execute milestones. Drive site-level activities at study level and/or area level, including site selection, activation, site engagement, protocol adherence and close out.
• Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable. Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan. Ensure sites are closed per Site Closure Plan.
• Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
• Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution. Ensure site compliance, elevate issues, and analyze trends for continuous improvement.
• Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts
• Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level

Qualifications

• Bachelors Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• A minimum of 5 years + of industry clinical research experience including 2 year of monitoring or project management or equivalent experience on a global study.
• Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
• 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 (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
• Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, 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

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus,commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolute discretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

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, visithttps://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