Project Manager/Lead (TIRKS)

Sincera Consulting - Charlotte, NC

Full-time - Mid Level

Charlotte, NC

Professional, Scientific, and Technical Services

About the position

The Project Lead will be responsible for managing the data loading process into TIRKS, ensuring compliance and data integrity while leading cross-functional teams. This role focuses on the extraction, transformation, and loading (ETL) of regulatory submission data, aligning with regulatory standards and improving data workflows.

Responsibilities

• Lead the planning, execution, and delivery of data loading projects into TIRKS, ensuring timely and accurate data integration.
• Manage cross-functional teams (Regulatory Affairs, IT, Data Management) to coordinate and implement data loading processes.
• Ensure data accuracy, integrity, and compliance with regulatory guidelines (FDA, EMA).
• Define data mapping and transformation rules for consistent integration across systems.
• Oversee the quality assurance process, conduct regular audits, and resolve data discrepancies.
• Provide project updates to stakeholders and manage risks, issues, and timelines.
• Identify and implement process improvements for data workflows and TIRKS functionality.

Requirements

• Bachelor's degree in Life Sciences, IT, Regulatory Affairs, or related field.
• 5+ years in data management or regulatory affairs, with 2+ years of project leadership experience in data loading or system integration (TIRKS preferred).
• Strong project management, leadership, and communication skills.
• Expertise in ETL processes and regulatory compliance.
• Familiarity with TIRKS or similar systems (e.g., Veeva, Documentum), and proficiency in data tools (SQL, Excel).

Nice-to-haves

• Project management certification (PMP) is a plus.