Country Study Start Up Specialist
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
- Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies. Competency in establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM Area SSU and CSM Lead Contract Manager CTS/Regulatory Affairs. Proactively identify and communicate issues impacting delivery and providing proposed solutions. Attend regional/area start up calls and provide input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA).
- Compile and submit ethics and other required local document packages including customization of ICFs patient facing materials and safety reporting. Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
- Collaborate with contract manager Site Monitor Area CSM Lead as required to assure timely site activation. Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas. Trigger clinical supply shipments. Complete IP release activities and triggering IP shipment. Issue site green light letter and activating sites in IXRS. Track all start up and maintenance related activities in Vault SSU as appropriate.
- Maintain local country and site intelligence database and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies. Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads. Ensure audit/inspection readiness.
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
- Participate in process improvement initiatives as required.
- Train and mentor new Country Start Up Specialists.
Qualifications :
Requirements:
- Bachelors Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
- A minimum of 1-2 years of clinical research experience and preferably 1 years of study start up management experience for the designated region.
- Experience working with remote/virtual teams.
- Strong interpersonal skills with the ability to build trust and communicate with clarity flexibility and adaptability to changing requirements.
- Demonstration of successful execution preferably in start up and aptitude for managing multiple priorities in a fastpaced environment.
- Working knowledge of ICH and GCP guidelines and operational understanding of the country & 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 :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
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
