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 at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Sr. SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position is assigned to studies as the overall CSM functional study strategy leader and single point of accountability for study level CSM deliverables from study planning to close out.
Influences and aligns within Clinical Development Operations and other key stakeholders in assigned studies. Accountable for planning and driving study-level CSM strategic planning and completion of deliverables by targeted timelines and with allocated resources for their assigned studies. Directs and coordinates site management activities in collaboration with assigned SMLs managing area site execution activities if applicable.
Accountable for driving overall study level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
Responsibilities
- 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 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 including site selection, activation, site engagement, protocol adherence and close out.
Oversee monitoring activities at study level in collaboration with 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 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.
Qualifications
- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- A minimum of 7 years of industry clinical research experience including 2 years of monitoring or project management or equivalent experience on a global study. Minimum 1 year global project management experience.
- 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 positively.
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
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