Country Study Start Up Specialist

3 weeks ago

Midrand, Gauteng, South Africa AbbVie Full time
Job Description

The Country Study Start Up Specialist plays a critical role in driving and executing all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.

Key Responsibilities:

  • Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies.
  • Establish 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 providing input for assigned sites/studies.
  • Collection of essential documents from sites and completing quality check (ALCOA).
  • Compile and submit ethics and other required local submissions 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, CRA, 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 and drive process improvement initiatives as required.

Qualifications:

  • Degree (degree in health care or scientific field)
  • A minimum of 3 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
  • Experience in VEEVA VAULT or similar Clinical Trial Management System for project management
  • Exposure in site selection, feasibilities and budget reviews
  • Experience working with remote/virtual teams
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
  • Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
  • Demonstration of successful start up and activation, and aptitude for managing multiple priorities in a fast‐paced environment.
  • Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.

Additional Information:

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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

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