Country Study Startup Specialist
Country Study Startup Specialist
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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 serving our community and embracing diversity and inclusion. It is AbbVies 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
