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About the Role
AbbVie is seeking an experienced Site Management Lead (SML) to play a pivotal role in the delivery of global clinical trials. This role offers the opportunity to influence study strategy, lead site management activities across multiple countries, and partner with cross-functional teams to deliver high-quality research. The SML will act as the primary Clinical Site Management representative within global study teams, providing leadership, operational expertise, and strategic oversight from study start-up through close-out.
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, escalate 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.
- Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
- Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.
Requirements
- 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 with a strong ability to create and deliver presentations.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
Skills
- Clinical trial delivery
- Site management
- Global clinical trials
- Study strategy
- Cross-functional team collaboration
- Operational expertise
- Strategic oversight
- Study start-up
- Study close-out
- Site monitoring
- Site engagement
- Protocol adherence
- Risk assessment and mitigation
- Inspection readiness
- Adverse event reporting
- Workplace Health and Safety (WHS)
- Business integrity
- Ethics and compliance
- Microsoft Word
- Microsoft PowerPoint
- Microsoft Excel
- Microsoft OneNote
Location
- Global
Work Type
- Full-time
Experience Level
- 5+ years of industry clinical research experience
- 2+ years of monitoring or project management or equivalent experience on a global study
Education Level
- Bachelor’s Degree in Science or Medical fields
About the Company
- 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.
- AbbVie is committed to transforming scientific discoveries into innovative medicines that improve the lives of patients worldwide.
- AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
- AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
- All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
- AbbVie is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
Equal Opportunity
- AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual.
- We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion.
- It is AbbVie’s policy to employ qualified persons of the greatest ability.
- We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status.
- Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing [email protected] or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.
- Equal Opportunity Employer/Veterans/Disabled.