Associate, RIM Data Management & Governance

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The RIMT function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA, IT, QA etc.). The Specialist/. Sr.Specilaist Data Management and Governance is responsible for managing and supporting central regulatory data entry into E2E RIM in compliance with internal/external data standards. This position is responsible for maintaining the data standards, controls and logic surrounding data fields in the BeiGene E2E RIM system and working closely with Data Governance team and other groups across the BeiGene. This role also has data quality and compliance responsibilities as assigned that could include the collection, maintenance, analysis, and reporting of metrics and data quality findings and to support ad-hoc reporting requests. This position will support and promote the value for centralized management and utilization of regulatory information/data.

Essential Functions of the job:

Primary Duties & Responsibilities:

• Responsible for management of all centralized RIM data entry needs for GRA.

• Ensure adherence to RIM data quality standards and compliant platform use through routine verifications, audits, resolution, and reporting.

• Supports Data Governance (DG) processes, and works to ensure DG Requests are resolved and, if approved, implemented correctly,

• Coordinates with Data Owners, Functional SMEs, System Owners, Business Admin (BA), vendors, IT, and DG teams to investigate, analyze and resolve the DG requests, impacts and related issues.

• Provides oversight for reporting and analytics activities of the RIM System.

• Manage and support ad-hoc reporting requests.

• Support to maintain data quality parameters, important metric reports and workflows to ensure that data is governed, consistent, reliable, and easily accessible.

• Supports any systems implementation and integration efforts with providing mapping of data and terminologies between systems, supporting interoperability.

• Promotes data literacy and understanding of data, definitions, and standards with cross-functional stakeholders/SMEs.

• Monitors regulatory agencies and industry standards for data related regulatory requirements (eg: IDMP, PQ-CMC, DADI etc..), and changes and version status-controlled vocabularies. Works to ensure BeiGene RIM data formats and terminologies stay current and compliant

• Authors and maintain Data Governance Job Aides describing detailed Data Steward activities.

• Provides guidance and sets standards of functional excellence in methodologies, processes, and SOPs to enable improvement of Global & Local BeiGene data …