Develop, coordinate, supervise and promote a variety of training, development and compliance programs designed to satisfy the quality system needs of the Renal Global Clinical Affairs Department in compliance with Corporate, Division and Global regulatory requirements.Support, develop and implement quality standards in the Clinical Affairs organizationManage performance of direct reports to ensure optimum function and utilization. Provide regular coaching and counseling, including field assessment of performance. Prepare and deliver performance reviews of direct reports. Partner with Human Resources (HR) and departmental management to address performance and/or disciplinary issues.Participating Member:Clinical Management Team (CMT)Renal Diversity & Inclusion Action Council (RDIAC)Corporate Committee for Common Standards for Clinical TrialsGrassroots Action Network (Government Affairs & Public Policy)

Manage performance of direct reports to ensure optimum function and utilization. Provide regular coaching and counseling, including field assessment of performance. Prepare and deliver performance reviews of direct reports. Partner with Human Resources (HR) and departmental management to address performance and/or disciplinary issues. Recommend personnel actions for direct reports (i.e., salary increases and promotions). Assist in the preparation and delivery of salary reviews for direct reports.Manage training and development of direct reports. Ensure reports receive departmental orientation, field and other necessary training. Provide leadership and motivation to direct reports and other department personnel. Serve as a model to departmental staff as relates to effective time/task management, communication and utilization of resources.

Responsible for assisting in the development and implementation of the GCP compliance strategy in collaboration with the clinical affairs, regulatory affairs and other appropriate functions. Responsible for specific audit tasks including FDA audits, internal audits, vendor qualifications, investigator site audits, database audits, Part 11 compliance audits and audit reports, corrective action requests and follow-up. Provide QA, ICH GCP, FDA CFR and EU Clinical Trials Directive support across the company.Develop and implement company GCP policies and guidelines. Assist in the development and implementation of RPS Total Quality Management program, and continue to monitor RPS’ compliance with the program. Coordinate consistency of policies, processes, and communication for Clinical Affairs. Provide QA support to computer systems validation activities.

Manages projects within clinical compliance and quality control program. Delegates assigned projects to direct reports and provides guidance/supervision. Train supplemental QC personnel to handle peak work periods. Supplies knowledge of relevant regulations and technical expertise to evaluate adherence to company, industry, and government standards. Develop SOPs for establishing and QC'ing Study Master Files. Develop SOPs for QC'ing: CRF, CRF Completion Guidelines, Monitoring Plans & conducting monitoring evaluations. Develop, track and report on QC metrics for clinical research. Assess compliance with Project Plans. Establish a schedule for and Document QC Inspections. Ensure resolution of discrepancies found during QC Inspections. Perform pre-FDA Quality Assurance audits of Investigative sites.

Hire, manage, and mentor Clinical Research Associates (CRAs). Develop and implement training programs and professional development for monitoring and clinical operations staff. Orient newly hired CRAs as well as reassigned CRAs to newly assigned projects. Develop Monitoring Services SOPs regarding monitoring procedures, monitoring compliance and reporting and management of Non-compliance or misconduct by a Clinical Investigators. Train newly hired CRAs to PharmaNet SOPs and policies. Provide in-house and field training for monitoring staff. Plan and conduct CRA site audits. Assess compliance with the protocol, PharmaNet monitoring SOPs, and GCP regulatory requirements. Plan and conduct audits of internal processes, Investigator sites, Study Master File and SOP compliance.