Senior Start Up Specialist
Petaling Jaya, Malaysia
Job Description
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General Tasks
- Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements
- Take ownership in the preparation (collection, organization and compilation) of routine submissions filed to IRB/EC/Third body/Regulatory Authorities (e.g. INDs/CTAs) including but not limited to the preparation of study documentation such as review/summarize scientific/research documents, country application form and cover letter for sponsor review as applicable
- Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable)
- Perform a review of final submission documents as applicable
- Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required
- Mentor and coach other Site Readiness and Regulatory Operations team members
- Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance without supervision and liaise with stakeholders as applicable in site activation related items
- When delegated by line manager, oversee and ensure quality data and audit readiness
- Participate independently and take lead (as applicable) in client meetings to proactively liaise on issues related to site activation and maintenance
- Develop project specific plans for the Site Activation component of assigned studies
- Review and approve projections and timelines to study teams, ensuring that they accurately represent the country\xe2\x80\x99s performance and suggests mitigation actions in agreement with line manager
- Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by line manager
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
- May take country lead role for specific projects/tasks with the applicable mentoring and supervision
- Proactively identifying, preventing and escalating to Submission Leads any risk to meeting deliverables and participate in strategy meetings to mitigate them
- Notify the Submissions Lead of hours identified as Out-of-Scope or over burn
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Job Detail
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Job IdJD924536
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationPetaling Jaya, Malaysia
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EducationNot mentioned