Manage GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, TMF audits, and applicable study document audits Serve as a QA representative to support clinical study teams and provide compliance advice during team meetings or other methods of communications Participate in review/approval of clinical study doc

Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator Function as an integral part of the research and comprehensive care teams Collaborate with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients and the department Create a study budget with the fina

Prepare all regulatory documents including IND, NDA, annual reports, and meeting briefing books Write day to day communication with the regulatory agencies Implement regulatory strategies (decided by the team) and incorporate those in the preparation of above regulatory documents and interactions Collaborate with the team to determine the regulatory strategy based on clin

Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection, and qualifications) Serve as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS, and other relevant requirements at partner suppliers/vendors

Oversee implementation of study level operational strategy for the successful of clinical studies Manage delivery of studies by CROs to ensure quality execution is aligned with time/budget forecasts Develop/amend specific sections of the protocol and related documents, study tools, guidelines, and training materials Collaborate with internal stakeholders to forecast and m

Execute supplier quality projects, including supplier change requests, process improvements, new supplier qualification, and receiving inspection Lead resolution of supplier related non conformances using problem solving tools (8D, Fishbone, 5 WHY's, etc.) Provide technical oversight for issue /problem resolution activities Drive process and product variance reduction uti

Prepare and/or review documents for submission to the US FDA (Module 2 and Module 3 documents, Annual Reports, Orphan Drug Applications) Organize and/or review documents for submission to foreign regulatory agencies (CTA, IMPD, NDS) Assess regulatory impact for any changes in the manufacture of drug products or drug substances Create regulatory submission strategy for pro

Conduct ongoing data reviews Prepare and present summaries to internal stakeholders Focus on data cleanup Ensure trial implementation according to the protocol Analyze information to assess issues relating to protocol conduct and/or individual subject safety EXPERIENCE Minimum of 4 years of experience in the pharmaceutical or biotechnology industry as a clinical scientist

Create plans/strategies and implement systems to ensure process performance Support the manufacturing processes daily Work with operations and various other departments to ensure quality performance of product/processes Lead and help develop the manufacturing processes for all products Resolve quality issues with suppliers and partner with internal customers Approve chang

Support successful execution of one or more clinical studies from study planning to close out Participate in vendor selection and contracting Oversee vendor performance and review vendor deliverables Contribute to the management of study finances by reviewing vendor contracts, budgets, and invoices Aid in the development of study timelines with internal study team and ext

Oversee clinical studies/vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonisation (ICH)/GCP guidelines Identify, engage, and manage the activities of clinical CROs and other clinical study providers Review and contribute to the development of st

Participate on the project team as a subject matter expert around process design/qualification Investigate NCMR/CAPAs Write, review, and complete process validations Ensure product requirements are being met through the design of the process Analyze information and come to conclusions based on presented data Present results in a logical and clear manner EXPERIENCE Minimum

Oversee the operational aspects of clinical trials Assist in project planning, timeline preparation, preparation, and review of study plans Manage CRO interactions and sponsor oversight of operational functional activities Prepare and review clinical documentation and other essential study documents/plans Contribute to protocol, strategy development, Clinical Study Report

Conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance to the protocol and Clinical Monitoring Plan Perform eCRF data review to identify trends, areas of risk, and address findings with site and/or CRO monitor Review MOVs from CRO and escalate monitoring trends/ findings to Monitoring Operations leadership Participate and provide input on site feasi

Plan and communicate with cross functional areas to ensure proper execution and conduct of assigned clinical trials Serve as primary contact and resource for CRO, vendor personnel, and internal team members Oversee and manage CROs, consultants, and vendors Supervise and oversee clinical studies ensuring they are conducted in compliance with the agreed study plans through