We are looking for a highly skilled and experienced professional to join our team as a Clinical Data, PV & Regulatory specialist in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a robust background in clinical data management, product validation, and regulatory affairs.
Roles and Responsibility
- Manage and analyze clinical trial data to ensure accuracy and compliance with regulatory requirements.
- Develop and implement effective data management plans to support product development and lifecycle management.
- Collaborate with cross-functional teams to ensure seamless execution of clinical trials and regulatory submissions.
- Conduct thorough reviews of clinical trial protocols, informed consent forms, and other regulatory documents.
- Provide expert guidance on clinical data management best practices and ensure adherence to regulatory standards.
- Develop and maintain relationships with key stakeholders, including investigators, sponsors,
and regulatory authorities.
Job Requirements
- Strong knowledge of clinical data management principles, including data modeling, data governance, and quality control.
- Experience with product validation (PV) and regulatory affairs, including FDA regulations and international regulatory frameworks.
- Excellent analytical and problem-solving skills, with the ability to interpret complex data sets and draw meaningful conclusions.
- Strong communication and interpersonal skills, enabling effective collaboration with diverse stakeholders.
- Ability to work independently and as part of a team, demonstrating a flexible and adaptable approach to changing priorities and deadlines.
- Strong attention to detail, ensuring high-quality deliverables that meet regulatory requirements.