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Trial Activation Approval Specialist

100% Remote Full-time Open now

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.

PPD-Pharmaceutical Product Development is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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