Manage the operational aspects of clinical trials Assist in project planning; timeline preparation, preparation and review of study plans, including the Clinical Monitoring Plan and review of eCRF guidelines/specifications Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project

In collaboration with product management, the Engineering Specialist, Systems Engineer will translate user needs into functional and non functional requirements and specifications to fully define necessary system features and functions In collaboration with product architects, develop system level architectures and associated diagrams In collaboration with cybersecurity l

Plan, identify, create, and produce promotional materials, programs, and activities needed to support brand strategies to meet business objectives. Collaborate with agency partners in the execution of strategic and tactical plans Effectively work with Promotional Regulatory, Legal, Medical and Compliance (PRC) partners to seek timely approval of promotional tactics. EXPER

Participate in implementing and maintaining a comprehensive risk based GCP compliance program Independently manage, conduct, and report assigned investigator site, vendor, and internal process/function audits on site and remotely according to Client's SOPs and using Client's systems effectively Review and approve audit responses and evaluate adequacy of corrective and/or

Coordinate all aspects of a clinical study Prepare and develop project and study related documents including informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols and amendments, and clinical summaries, as required Assist with managing study contracting, budget, invoicing and payment process for all clinical trial vendors includi

Provides operational and strategic leadership for Global Safety Services (GSS) to achieve the goals of Advanced Clinical. Manages projects by coordinating the work of the Global Safety Services staff, and if necessary, contractors to assure deliverables meet internal quality standards, are compliant with global Regulatory Authority regulations, are on time, and within bud

Support company goals and objectives, policies, and procedures Drive CAPA processes, complaint handling processes, and processing of returned material authorizations, including root cause investigation and closure Manage the internal audit process and management review Manage supplier quality assurance (i.e., supplier evaluations, audits, etc.) Conduct regular quality ins

Acquire and maintain end to end product knowledge enabling a contextual understanding of designated product(s) from development through current day. Partner with relevant teams to highlight potential quality issues during development, manufacturing and testing and identify/execute strategies to effectively manage them. Collaborate with key CMC stakeholders on development

Plan and manage study startup including site identification, qualification, selection and initiation activities Lead Clinical Monitoring activities through site activation, maintenance and study closure Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to Monitoring standards (During all stages of the trial) Communication plan Selection, qualificati

Supports the setup and maintenance of the Client's Global Development Quality Management System (clinical QMS). Ensures the implementation and maintenance of processes for Client's Procedural Document Management, Training/Learning Management System and Management of GCP Deviations, including Serious Breaches. Supports the implementation and maintenance of processes for Cl

Support and collaborate with Client's key stakeholders in portfolio and study teams to ensure that risks are detected and remediated Provide guidance to day to day questions arising from Clinical trials deliverables Interact with CROs to ensure adequate quality oversight on clinical activities Collaborate with Clinical Development Operations to drive initiatives relevant

Maintain operational readiness of cGMP automation systems Collaborate with manufacturing/other end users to develop functional requirements, implement necessary changes, and improve the automation system's overall reliability/efficiency Design, implement, and test automation solutions/strategies based on functional requirements and change control management processes Supp

Seek to make continuous improvements to design of Automated system, execution, and automation Collaborate effectively and on an ongoing basis with various internal teams Share automation related issues and provide recommendations based on issues discovered Create a sustainable automation framework for many large scale and highly integrated applications (PLC based, DELTA V

Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies Provide strategic guidance and direction to cross functional study teams to ensure successful study execution Ensure that clinical studies are conducted in accordance with approved protocols, ICH GCP, EMEA, PMDA and oth

Responsible for the implementation and quality execution of assigned clinical protocols according to client SOPs, ICH/GCP, and corporate and departmental program goals Serves as a Study Lead to the multifunctional team to ensure clinical study/studies activities including study start up, enrollment, maintenance, and close out are executed per timeline and budget Oversees