Lead the internal Quality Management System (QMS) continuous improvement efforts and electronic Quality Management Systems (eQMS) enhancement efforts Assess globally the impact of system changes to existing modules Manage the maintenance of SOPs, training programs, deviations, CAPAs, commercial/investigational product complaints, vendor qualification/auditing, and the doc

Support data management to serve clinical studies performed Provide clear verbal or written information and hands on support to project team members/CROs related to CRF design, data management plans, edit checks/quality review plans, and query resolution processes Assist with data transfers for CROs, SAE/AE reconciliation, and thesaurus coding processes Manage the locking

Liaise with other function heads to ensure effective cross functional collaboration and proactive communication throughout the drug development process Represent Data Management in governance bodies internally/externally with CRO partners and stakeholders Serve as the Data Management leader representing R&D during regulatory inspections and internal audits pertaining to R

Assess current portfolio, program, and project management practices and develop solutions to improve those capabilities Facilitate a variety of working sessions including process development, project planning, and risk assessment Understand organization change management techniques and interventions aimed at fostering adoption of new ways of working Coordinate performance

Plan, coordinate, and execute all operational activities required for the collection, delivery, and testing of clinical samples within the clinical study Manage vendor (minimum 4 vendors), generate lab manuals, collect samples and shipping logistics, plan scenarios, forecast high level timelines, assess program level feasibility, estimate budget/resources, and develop hig

Build efficiencies in the Biostats department to streamline programming efforts related to safety review deliveries and QC checks Manage SAS programming QC of summary tables (efficacy, safety, demographics, disposition, and exposure) for internally produced displays and displays provided by 3rd party vendors Generate high quality subject listings and graphs to support saf

Plan and oversee the successful delivery of long and short term program objectives Collaborate with the project leader and team to update program driven business plans, budgets, forecasts, and report actual performance against plan Identify risks and manage those with understanding of impact for this program and others Develop, maintain, and align a program timeline, reso

Facilitate scheduling of third party auditors for the execution of supplier audits Plan and perform audits according to the requirements specified in internal SOPs Prepare audit reports for third party and/or company executed audits Enter audit reports into internal electronic system according to company requirements and timelines Assess the adequacy of responses to audit

Establish, lead, maintain, and motivate high performance cross functional project teams while serving as the project advocate within the organization Cultivate collaborative professional relationships with peers and stakeholders Actively transform insights into actions, drive results, and contribute to a continuous learning culture Execute several projects concurrently wi

Provide representation for study level regulatory activities and updates in study team management meetings Support clinical trial application activities and reviews Approve investigator essential document packages Manage and track commitments to regulatory agencies Collaborate with subject matter experts to provide written responses to Health Authority queries, and provid

Propose measures aiming at minimizing risks during clinical development Update and release the Development Risk Management Plans (DRMPs) Interact with internal/external stakeholders to ensure monitoring of safety profile for assigned compounds, signal validation/signal evaluation, and propose appropriate risk management/minimization measures Review and provide input into

Participate in Project Team Meetings and Vendor selections Manage project KPIs per the scope of work and within the contracted budget Ensure project is conducted according to company and CRO SOPs Develop plans to achieve contracted milestones, monitor project progress against the established plans, and ensure compliance with plans Serve as primary project contact and esca

Develop manufacturing processes to support clinical studies and the commercialization of internal products Establish robust process specifications for the validation of manufacturing processes using Design of Experiments (DOE) and statistical analysis Drive continuous improvement initiatives (lean manufacturing, risk assessments, and cost/benefit analysis) Manage external

Collaborate with molecular and computational biologists, data scientists, and software engineers to evaluate new technologies Utilize Good Laboratory Practices to perform mission critical experiments to help optimize the performance of internal assays Prototype new next generation sequencing (NGS) methods Optimize the performance of existing assays Execute biomarker disco

Lead development of CMC strategies from early clinical manufacturing to commercial production. Ensure compliance within CMC manufacturing and oversight of Contract Manufacturing Organizations and testing Labs. Initiate process improvement and process control procedures for cGMP manufacturing and product quality. Provide technical oversight of batch records, protocols, cha