
Trial Activation Approval Specialist
We are currently looking for an experienced and enthusiastic Trial Activation Approval Specialist to join the PPD-Pharmaceutical Product Development team. In this role, you will be responsible for providing trial activation expertise, ensuring all applicable regulatory requirements are met to guarantee the activation of clinical trials in compliance with applicable regulations. To be successful in this role, you must possess a strong understanding of the regulatory and clinical trial process, as well as excellent communication and organization skills. If you have a passion for the clinical research field and thrive in a fast-paced environment, then this may be the perfect opportunity for you!
Responsibilities:
- Monitor trial activation and ensure all applicable regulatory requirements are met.
- Evaluate and assess clinical trial protocols and related documents to ensure compliance with regulations.
- Communicate with internal and external stakeholders to ensure all trial activation activities are completed accurately and in a timely manner.
- Provide guidance and advice to clinical trial teams on applicable regulatory requirements.
- Develop and maintain up-to-date knowledge of regulatory and clinical trial process.
- Prepare and submit regulatory documents for trial activation.
- Document all trial activation activities.
- Monitor and report on trial activation status and progress.
- Liaise with regulatory authorities to ensure timely activation of clinical trials.
- Maintain effective working relationships with internal and external stakeholders.
Excellent Written And Verbal Communication Skills
Strong Interpersonal Skills
Ability To Handle Multiple Tasks Simultaneously
Knowledge Of Data Privacy Regulations And Laws
Familiarity With Clinical Trials And Data Management
Ability To Work Independently And Collaboratively
Strong Problem Solving And Analytical Skills
Proficiency With Microsoft Office Applications
Documentation
Quality Assurance
Process Improvement
Project Management
Data Analysis
Communication
Clinical Research
Problem Solving
Database Management
Technical Writing
System testing
Risk assessment
Regulatory compliance
Report generation
Protocol Development
Communication
Leadership
Problem Solving
Time management
Interpersonal Skills
creativity
flexibility
Organizational skills
Teamwork
Adaptability
According to JobzMall, the average salary range for a Trial Activation Approval Specialist is around $47,000 to $61,000. The salary range may vary depending on experience, location, and other factors.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

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