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

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

Analyze production/processing problems and initiate project definitions to resolve them Ensure timely and within budget completion of the projects as assigned Evaluate the feasibility of conceptual projects and prepare detailed analysis (time/cost for completing the projects) Verify that assigned projects are in compliance with State, Federal, and local codes which encomp

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

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

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

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

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

Solve challenging workplace problems Learn and become system owner of support systems Prepare documents to include maintenance, quality, production, and reports Communicate status of work assignments as requested Support workplace continuous improvement projects Interact with plant functions (quality, production, facilities, purchasing, validation, tech services, etc.) to

Identify, manage, and perform internal/external GCP audits Write, review, and approve GCP documents (agreements, plans, and reports) Perform and/or oversee internal/external GCP quality investigations to ensure that issues are thoroughly evaluated and appropriate actions are taken Provide GCP guidance to ensure compliance with applicable regulations Innovate processes and

Oversee routine study sample management operational activities Track clinical trial samples from sample receipt to result reporting to investigator sites and/or external collaborators Escalate cases with no movement in lab processing or logistical sample return issues to Study or CTS Lead Monitor incomplete specimen sets and provide timely resolution of aging cases beyond

Identify, develop, and maintain relationships with thought leaders Collaborate cross functionally to contribute to scientific communications/publications plan Develop a medical education plan by identifying gaps in current knowledge and apply deep therapeutic area insights to action Lead MSLs in delivering timely, objective, scientific, and economic information/education

Lead the statistical and programming activities in ISS/ISE to support BLA Perform, advise, and review protocol development, sample size calculation, protocol, and CRF review Ensure the accurate programming of SAS clinical data extracts and data displays Provide statistical input into and perform review of SAPs, table shells, programming/table specifications, TLFs, and sta

Arrange and coordinate domestic and international travel, meetings, conference calls, and related scheduling (including last minute changes) Complete and submit complex expense reports, word processing of letters, contracts, and other documents Manage and coordinate vendor invoicing, telephone coverage, faxing, scanning, and photocopying of documents Process and distribut

Develop an understanding of the regional landscape including specialties involved in care of patients Generate and execute tactical regional plans to provide need based, value added support of the medical/scientific community in line with company goals Support clinical development initiatives Collaborate with key internal/external stakeholders on Medical Affairs initiativ