Senior Specialist, Country Study Start Up
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Job Location:
Seoul - South Korea
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities:
- Drive and execute all start-up and maintenance activities for assigned studies and sites within the country (or countries).
- Ensure on-time on-budget quality delivery of start-up and maintenance activities particularly for single-country studies.
- Act as a site start-up expert; support train and mentor Specialists Country Start Up in new technologies and processes.
- Establish country/site activation plans risk assessment and mitigation in collaboration with cross-functional leads.
- Proactively identify communicate and address issues impacting study delivery.
- Attend regional/area start-up calls and provide study/site input.
- Collect and quality check essential documents from sites (using ALCOA standards).
- Prepare and submit ethics and local required submissions customize ICFs and patient/safety materials.
- Coordinate with Regulatory and CTS for CA submission and approval alignment.
- Collaborate with contract manager CRA and other leads for timely site activation.
- Review and process comments on ICFs from sites/IRB/ECs; obtain necessary approvals.
- Trigger clinical supply shipments and complete IP release processes.
- Issue green light letters and activate sites in IXRS.
- Track all start-up and maintenance activities in Vault SSU; maintain site intelligence and EDLs.
- Maintain performance metrics and KPIs; update stakeholders on progress.
- Ensure audit/inspection readiness and compliance with corporate policies and global regulations.
- Lead process improvement initiatives to enhance site start-up efficiency.
- Function as a subject matter expert and trainer for Specialists Country Start Up.
Additional Information :
Required Qualifications:
- Bachelors degree (health care/scientific discipline preferred) or equivalent experience.
- At least 6 years of clinical research experience; ideally 2 years in study start-up management for the relevant region
- With regulatory submission experience will be highly preferred
- TA area in oncology or immunology experience is preferred
- Hands-on experience with regional clinical research regulations and processes.
- Experience with central/local IRB/EC sites particularly ICF review/approval processes.
- Competency with Vault SSU for document processing IP release ICF review.
- Experience working with remote or virtual teams.
- Strong analytical critical thinking and decision-making skills.
- Excellent interpersonal communication skills; ability to adapt to changing requirements.
- Proven track record of managing multiple priorities in a fast-paced environment.
- Demonstrated initiative and leadership in projects supporting the business.
- Working knowledge of ICH/GCP guidelines and the countrys regulatory landscape.
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 :
Full-time
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About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
