* Adhere to applicable Sponsor SOPs, work instructions, policies, and local regulatory requirements.* Support central study teams (including trial managers, data managers, study physicians, study scientists, quality colleagues, and statisticians) in identifying critical study data, processes, and associated risks.* Coordinate translation of identified risks and critical data/processes into risk mitigation and oversight plans, including Quality Tolerance Limits (QTLs), to be followed during study execution.* Support appropriate decision-making related to site management, data review, and contingency planning, and provide input into study plans.* Coordinate with cross-functional study teams to ensure compliance with established risk oversight plans and oversee site risk parameters.* Conduct ongoing study and operational data reviews and follow findings through resolution, including development of Site Mitigation Plans, in collaboration with central and field teams.**Followed by proper in...