Country Study Start Up Specialist (Hybrid)

The Country SSU Specialist proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

This role is hybrid (onsite Tuesday - Thursday remote Mondays and Fridays).

Responsibilities :

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM Area SSU and CSM Lead Contract Manager CTS/Regulatory Affairs. Proactively identify and communicate issues impacting delivery and providing proposed solutions.
• Attend regional/area start up calls and provide input for assigned sites/studies.  Collection of essential documents from sites and completing quality check (ALCOA). 
• Compile and submit ethics and other required local document packages including customization of ICFs patient facing materials and safety reporting. 
• Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements. 
• Collaborate with contract manager Site Monitor Area CSM Lead as required to assure timely site activation. Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas. 
• Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
• Maintain local country and site intelligence database and EDLs in Vault.
• Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.  
• Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines. 
• Participate in process improvement initiatives as required. 
• Train and mentor new Specialists Country Start Up 

Qualifications :

Minimum Qualifications:

• Bachelors Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required 
• A minimum of 1-2 years of clinical research experience (CRO or Sponsor)

Preferred Qualifications:

• 1 years of study start up management experience for the designated region. 
• Experience using Veeva Clinical Platform
• Experience with informed consent reviews

Other Required Skills:

• Experience working with remote/virtual teams 
• Strong interpersonal skills with the ability to build trust and communicate with clarity flexibility and adaptability to changing requirements. 
• Demonstration of successful execution preferably in start up and aptitude for managing multiple priorities in a fastpaced environment. 
• Working knowledge of ICH and GCP guidelines and operational understanding of the countrys regulatory environment. 

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. 

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. 

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

No

Employment Type :

Full-time