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 strong 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.

Clinical Data, PV & Regulatory Professional

Job Description

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