Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation ā¢ Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports ā¢ Contribute to contract review and negotiations with outside vendors and study sites or laboratories ā¢ Mentor CTMs and CRAs ā¢ Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: ā¢ Bachelors degree or higher, or equivalent credentials ā¢ Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements ā¢ Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): ā¢ Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out ā¢ Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings ā¢ Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable ā¢ Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials ā¢ Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6.