Global Site Management Lead

Purpose

Describe the primary goals objectives or functions or outputs of this position.

The GSML reports into the Associate Director Global Site Management and 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 as the global study strategy leader serving as the overall CSM functional leader and single point of accountability for study level CSM deliverables or can be assigned as an area site execution leader to manage area level site management activities in collaboration with an assigned global study strategy leader dependent on size complexity and geographic scope of assigned studies.
Influences and aligns within Clinical Development Operations with the assigned global site management leader if applicable and other key stakeholders in assigned studies. If assigned as the global site management leader is a key member of the Clinical Study Team representing CSM globally.

Responsibilities

• Champion AbbVies Risk Based Quality Management framework ensuring implementation on assigned studies. Develops and drives operational study-level or area-level strategy to be executed by site monitors in selected countries for assigned studies including risk identification evaluation root cause analysis and mitigation to establish alignment with overall study or area level execution.
• Communicates and manages identified risk through development of effective mitigation and action plans at study-level and/or area level. Works with other Site Management Leads Country Leaders and other functions to action. Provides leadership and CSM expertise on cross-functional workstreams and initiatives for process improvement.
• If assigned as the global study strategy leader is a key member of the Clinical Study Team representing CSM globally from study planning through study closeout. Actively contributes to planning and execution of assigned clinical studies including content of the protocol study plans and data cleaning (e.g. Site Monitoring Plan IDRP RAMP Site Engagement Strategy Data Cleaning Plan etc.).
• 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. Ensures issues/deviations are entered escalated and actioned in a timely manner. Analyzes emerging trends and escalates to the assigned global site management leader Clinical Study Leadership and Country Leadership as applicable.
• Proactively communicates and supports CSM resource planning with Country teams (COM / CCOM) in alignment with the study deliverables and milestones. Manages and oversees day-to-day monitoring activities at study strategy level and/or area execution level as applicable to ensure CSM deliverables are met by tracking and maintaining metrics and status of deliverables.
• Proactively communicates and escalates issues risks and mitigation plans to Clinical Study Leadership Country Leadership and the assigned global site management leader as applicable. Provides input into vendor selection and content of site-facing vendor platforms. Maintains knowledge of ICH/GCP regulatory requirements AbbVie SOPs and assigned Therapeutic Area.
• Partners with stakeholders (Clinical Study Leadership Clinical Development Medical Affairs DSS CDSM SSU and CSM Country leaders etc.) in developing overall study planning or area execution 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/Responsible for driving study strategy level and/or area execution level site management activities from study start-up through study closeout ensuring delivery of site selection site activation in collaboration with SSU Site Engagement Strategy/implementation recruitment protocol compliance data quality and adherence to monitoring plan. Accountable for site-level risk assessments risk mitigation execution and remediation of site-level non-compliance in partnership with CSM
• Accountable/responsible for the development and/or execution of the Site Monitoring Plan (SMP) and delivers SMP related training in collaboration with other assigned Site Management leaders if applicable. Provides CSM input on study-specific site monitor training plans and training materials site staff and patient facing materials. Serves as the CSM SME for inspection readiness and TMF completeness always ensuring study and site inspection readiness. Assists with audit responses as applicable
• Generates lessons learned at study strategy level or area execution level in collaboration with other Site Management leads and functional stakeholders as applicable. Shares and implements best practices within CSM. Contributes to improving CSM efficiency which may include participating in Continuous Improvement Initiative(s). Champions change management in the adoption of new technologies and processes in assigned studies to support consistency and operational excellence in CSM execution.

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 years 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-patient). 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. Demonstrates critical and proactive thinking.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages 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 benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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. 

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Work :

Yes