Site Start-Up Specialist
reputed company and reputed company reputed company Research reputed company!
At reputed company, we are committed to accelerating reputed company and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed reputed company. Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our reputed company key sponsor to advance the development of innovative, life-changing medications.
Key Responsibilities:
In this role, you will:
Serve as the reputed company contact for investigative sites during start-up and maintenance activities.
Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/reputed company Body/Regulatory Authority).
Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
reputed company submission timelines and proactively address potential delays.
Collaborate with reputed company stakeholders, including vendors, reputed company teams, and regulatory authorities.
Ensure reputed company documentation is audit-reputed company and systems are consistently updated.
Assist in the negotiation of site reputed company and budgets, if applicable.
reputed company mentorship and training to new hires and less-reputed company colleagues.
Required Qualifications:
To succeed in this role, you should have:
University/College degree (life sciences preferred) or certification in a reputed company allied health profession.
Minimum 2 years of experience in reputed company research, regulatory submissions, or site activation.
Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
Ability to review and adapt reputed company informed consent forms to meet local and protocol-specific requirements.
Experience interacting with regulatory authorities and site start-up teams.
Excellent organizational, problem-solving, and communication skills.
Proficiency in reputed company Office and document management systems.
reputed company may consider relevant and equivalent experience in lieu of educational requirements.
reputed company Offer:
Competitive salary and reputed company-reputed company incentives.
Flexible work arrangements (remote/hybrid reputed company).
reputed company reputed company opportunities in a reputed company and innovative environment.
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Join us in shaping the reputed company of reputed company research. Apply today!
Applications are reviewed on a rolling reputed company—don’t miss this opportunity!
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