Clinical Start-Up Specialist (Country Focus)

AbbVie; Maidenhead; Sur place; GBP 50 000 - 80 000; Plein temps

Résumé du poste

AbbVie is seeking a Specialist, Country SSU to proactively drive and execute start-up and maintenance activities for assigned studies and sites in the country. You will coordinate site activation plans, perform quality checks, and manage regulatory submissions while ensuring timely delivery.

Responsibilities include IP release, IXRS activation, data tracking in Vault, and maintaining site intelligence. Strong clinical research experience and cross-functional collaboration are essential.

Qualifications

• Bachelor's Degree (health care or scientific field) preferred or equivalent experience.
• Minimum clinical research experience; study start up management experience preferred for the region.
• Experience working with remote/virtual teams.
• Strong interpersonal skills; ability to build trust and communicate clearly, flexibly and adaptably.
• Demonstrated execution in start up; ability to manage multiple priorities in a fast-paced environment.
• Working knowledge of ICH and GCP; understanding of local regulatory environment.

Responsabilités

• Ensure successful, on-time, quality execution of start-up and maintenance activities for assigned sites and studies.
• Coordinate country/site activation plans and priorities with stakeholders; identify issues and propose solutions.
• Attend regional start-up calls; collect essential documents and perform quality checks (ALCOA); prepare ethics and local document packages including ICFs and patient materials.
• Collaborate with Regulatory and CTS on CA submissions and approvals; coordinate with Contract Manager, Site Monitor, Area CSM Lead to ensure timely activation.
• Trigger clinical supply shipments; complete IP release activities and IP shipments; issue site green light letters; activate sites in IXRS.
• Maintain local country/site intelligence database and EDLs in Vault; monitor SSU KPIs and report to leaders.
• Ensure audit/inspection readiness and compliance with corporate/divisional policies; participate in process improvements.
• Train and mentor new Specialists, Country Start Up.

Connaissances

Clinical research experience

Study start up management

Remote/virtual teamwork

Interpersonal skills

Communication & adaptability

Multi-priority management

ICH & GCP knowledge

Formation

Bachelor's Degree in health care or scientific field

Outils

Vault SSU

IXRS

ALCOA principles

Description du poste

AbbVie is seeking a Specialist, Country SSU to proactively drive and execute start-up and maintenance activities for assigned studies and sites in the country. You will coordinate site activation plans, perform quality checks, and manage regulatory submissions while ensuring timely delivery.

Responsibilities include IP release, IXRS activation, data tracking in Vault, and maintaining site intelligence. Strong clinical research experience and cross-functional collaboration are essential.