Clinical Project Manager (QMS)

Nextonic Solutions LLC•Bethesda, MD

11d

About The Position

Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Project Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID), Office of Clinical Research Affairs (OCRA). Requirements: Provide quality management support for Division clinical research activities. Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID – inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities. Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents. Support the development and implementation of the Division’s electronic Quality Management System (eQMS). Stay current with changes to current industry standards and applicable regulations for quality in clinical research. Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPA's for internal & external audits. Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events. Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies. Review, track and/or trend routine quality data. Report adverse trends to management with proposed remediation plan. Coordinate the development of various QA related metric reports. Work with other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID. Based on understanding of Division Operations, look for ways to standardize processes in-order to improve quality and/or facilitate efficiency.

Requirements

Bachelor’s degree in a related discipline.
Minimum of five (5) years of experience in clinical research or a related field.
Experience in establishing and managing quality management systems for clinical research for IND sponsors (e.g. in pharmaceutical companies, biotechnology companies, or government sponsors).
Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes.
Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
Excellent communication skills both verbally and written; and across functions internally and external.
Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in-order to effectively solve problems.
Excellent multi-tasking, analytical, organizational and teamwork skills.
Ability to troubleshoot, identify root cause and systematically resolve problems.
Ability to produce high-quality work on complex problems with cross-functional involvement.
Proficient in Window based software to include Excel, Word.

Nice To Haves

Knowledge of electronic clinical quality management systems such as Master Control is preferred.
Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
Experience conducting or overseeing audits is preferred.
Experience working at a clinical research site is preferred.
Experience in the NIH or other government agency is preferred.

Responsibilities

Provide quality management support for Division clinical research activities.
Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID – inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities.
Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
Support the development and implementation of the Division’s electronic Quality Management System (eQMS).
Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies.
Review, track and/or trend routine quality data.
Report adverse trends to management with proposed remediation plan.
Coordinate the development of various QA related metric reports.
Work with other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID.
Based on understanding of Division Operations, look for ways to standardize processes in-order to improve quality and/or facilitate efficiency.