Data Governance Specialist
This role is pivotal in promoting data stewardship, enhancing data quality and ensuring the principles are embedded in the site culture.
Key Responsibilities:
* Design and deliver continuous Data Governance Training in line with current and evolving required DG knowledge, skills and awareness needs.
* Conduct training needs assessments to identify training gaps and areas for improvement.
* Collaborate with department leadership to ensure DG training aligns with operational needs and business objectives.
* Assess the impact of industry trends and regulatory updates on training needs and program content and adjust training strategies where necessary.
* Leverage technology to enhance training delivery, including e-learning platforms, simulation tools, and virtual training environments.
* Build awareness through engagement with employees of the need for and the desire to build and role model a mature DG culture.
Requirements:
* Demonstrated success in designing, implementing, and managing training programs for diverse audiences.
* Strong facilitation, communication, and organisational skills.
* Experience with training management systems and e-learning tools (e.g., LMS, Articulate).
* Strong analytical skills and attention to detail.
* Stakeholder management and influencing skills.
* Experience in cultural/people change management and organisational development.
* Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
Education and Experience:
* Bachelor's degree or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.
* 5+ years of professional experience or equivalent in pharmaceutical/FDA regulated work areas.