Country Study Startup Specialist
Country Study Startup Specialist
Posted on :
22-04-2025
Employer Active
1 Vacancy
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Job Description
- Purpose:
- Drive and execute startup and maintenance activities for assigned studies and sites within the assigned country or countries.
- Responsibilities:
- Ensure successful timely and quality of startup and maintenance activities for assigned sites/studies focusing on central IRB/EC sites.
- Establish country/site activation plans and priorities including risk assessment and mitigation plans.
- Identify and communicate issues impacting delivery and provide solutions.
- Attend regional/area startup calls for input on assigned sites/studies.
- Collect essential documents from sites and conduct quality checks.
- Compile and submit ethics and other required local submissions.
- Coordinate with regulatory and CTS on CA submissions and approvals.
- Collaborate for timely site activation and review comments on ICFs.
- Trigger clinical supply shipments and complete IP release activities.
- Issue site green light letters and activate sites in IXRS.
- Track startup and maintenance activities and maintain performance metrics.
- Ensure audit/inspection readiness and compliance with policies/procedures.
- Participate in process improvement initiatives.
Qualifications :
Qualifications:
- Required:
- Bachelors Degree in healthcare or scientific field preferred or equivalent experience.
- Minimum of 12 years of clinical research experience with preference for 1 years in study startup management in the designated region.
- Experience working with remote/virtual teams.
- Skills:
- Strong analytical and critical thinking skills.
- Ability to build trust and communicate effectively.
- Successful and ability to manage multiple priorities.
- Working knowledge of ICH and GCP guidelines and the regulatory environment.
Additional Information :
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 :
Fulltime
Employment Type
Full-time
Key Skills
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