Global Clinical Trial Site Management Lead/ Sr. GSML
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This role can be hired at a GSML/ Sr. GSML level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities
Purpose: The Global Clinical Trial Site Management Lead (GSML)/ Sr. Global Site Management Lead (GSML) reports into the TA Director, Global Site
Management and provides leadership and content expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The role serves as a single point of accountability for global CSM study-level deliverables at global level and influences and aligns within Clinical Development Operations and other key stakeholders across the organization. Key member of the Core Study Team Operating Model. Accountable for planning and driving global study-level CSM deliverables by targeted timelines for their assigned study(ies). Serves as a primary CSM functional leader and interface for Study Team and CSM in their assigned study/ies. Directs day to day activities of assigned ASML(s).
Role can be based virtually across the U.S.
Primary responsibilities include but not limited to:
- Develops and Drives operational study-level strategy to be executed by CSM Country teams, including risk identification, evaluation, and mitigation to establish alignment with overall study execution. Identifies risk to CSM deliverables and effectively communicates them within CSM (global, area and regional level) and to the Core Study Team. Manages identified risk through development of effective mitigation and action plans at study-level. Works with ASML, Country Leaders and other functional areas, as appropriate, to drive implementation of mitigation and action plans.
- Member of the Core Study Team, representing CSM globally from study planning through study closeout. Actively contributes to planning and execution of the clinical programs including content of the protocol and study plans (e.g. IDRP, RAMP, Recruitment Strategy and Plan). Provides input into vendor selection and content of site-facing vendor platforms.
- Accountable for CSM study execution and oversight of timeline development and adherence through the study lifecycle. Includes working with CSM country leadership to ensure LBEs meet overall study timelines and, if not, establishing a risk mitigation plan for discussion with the study team and ensuring all participating countries are informed and aligned to the overall timelines for the study.
- Partners with stakeholders (Clinical Study Leadership, Study Performance & Delivery, CTRG, DSS, CDSM and CSM Country leaders, etc.) in developing overall study planning for CSM deliverables and dependencies, using analytics and country intelligence to enhance the Country and Site selection process. Ensures CSM Country leaders receive appropriate and timely study information, documentation and tools to allow for plans to be executed as per targeted milestones.
- Accountable for driving site management activities from study start-up through study closeout ensuring delivery of site selection/activation, subject recruitment, protocol compliance, data quality and adherence to monitoring plan.
- Provides the perspective of the CSM organization, investigators, and patients, for the development of study documents, including, as applicable, CRA training delivery plans and materials, site staff and patient facing material.
- Accountable for site-level risk assessments, risk mitigation execution and remediation of site-level non-compliance.
- Serves as the CSM SME for inspection readiness, ensuring study and site inspection readiness at all times. Assists with audit responses, as applicable.
- Accountable for the development of the study monitoring plan (SMP) and delivers SMP related training. Provides CSM input on study-specific CRA training plans and training materials, site staff and patient facing materials.
- Has input on day to day activities of assigned ASML(s) via matrix reporting
- Leads change management in the adoption of new technologies and processes in the assigned study(ies) conduct to support consistency and operational excellence in CSM overall execution. Develops global CSM lessons learned for the assigned study(ies)with appropriate stakeholders. Shares and implements best practices within CSM. Contributes to improving CSM efficiency, which may include participating in Continuous Improvement Initiative(s).
- When applicable, responsibilities include participating in the vendor selection process and managing clinical site management vendors. Accountable for supervising CRO oversight and issue escalation related to CRO monitoring activities.
- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- A minimum of 5-7 years + of industry clinical research experience including 1 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, fastpaced environment.
- Able to work well within a team and autonomously. Thinks proactively.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 25 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.