Country Study Start Up Specialist

2 weeks ago


Maidenhead, United Kingdom ABBVIE Full time

**Country Start-Up Specialist (SSU)**
- Flexible working and fully, home-based
- New position for the UK team, part of the largest European Hub for Clinical Development
- AbbVie offers excellent career pathway and progression, home working arrangements, performance bonus, private medical/ dental cover and share scheme

**Job Overview**:
Country SSU Specialist proactively drives all start-up activities, in the scope of UK and Ireland. Involved in study accountable for on-time, budget and quality delivery and leading from site feasibility to site activation of our AbbVie clinical trials. Using new technologies and processes, you will be the site start up expert and providing support across the process. Collaborating closely with the wider clinical team and cross-functional teams.

**Responsibilities**:

- Assigned to AbbVie studies to oversee start-up activities including site feasibility, site activation and submission to ethics committees
- Completion of ethics submissions; using your local regulatory expertise to ensure timely completion of study start-up deliverables
- Lead site activation process; assisting UK and Ireland CRA team throughout the process
- Anticipate and identify site issues that could affect timelines and develop alternative solutions
- Collaborate on projects to innovate ways of working, to improve quality and share best practice globally
- Experience within study start up; experience in site monitoring (would be preferable, not essential)
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations
- Strong analytical individual
- Excellent interpersonal skills, and ability to communicate with clarity



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