The Line Manager, Clinical Monitoring FSS (LMCM) is responsible for oversight of all activities related to clinical monitoring as they pertain to a specific client and/or Functional Service Provider (FSP) program. As part of the dedicated client FSP team, the LMCM's responsibilities include but are not limited to resource management, assurance of quality data, and deliver

Provides technical expertise in all facets of Active Pharmaceutical Ingredient (API) process development and research and development activities. Develops, plans, and executes experiments independently and communicates results to various stake holders and external entities including non technical personnel. Subject matter expert in the field, keeps abreast of the latest r

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Senior NPI Engineer Manager, in Redwood City, CA. The Senior NPI Engineer Manager role will be able to work in a highly matrixed and geographically diverse business environment. The successful candidate will have strong leadership skills, including the ability to set goa

Understand knowledge transfer steps and how to perform show/tell training, including basic training material creation Application device troubleshooting skills Managing successful resolutions of technical issues through vendor support tickets and resolution pathways Strong organization and communication status updates to ERP project team and business stakeholders for work

The Senior Medical Director serves as the primary medical point of contact for a project or study. The Senior Medical Director effectively manages medical and safety review, processes, and projects inclusive of medical and safety monitoring for assigned clinical studies. Responsibilities Assists with RFP/RFI completion and attends sales meetings as requested by Business D

Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects Verify adequacy, completeness, reliability, and quality of trial data collected at stud

Independent SAS programming QC of summary tables (efficacy, safety, demographics, disposition and exposure) for internally produced displays and displays provided by third party vendors. Generating high quality subject listings and graphs to support safety review. Generating displays to help the clinical team interpret study results and/or query outliers. EXPERIENCE At le

Lead in the preparation and submittal of regulatory applications and on going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (e.g., IND, NDA and MAA,). Participate in project planning meetings to provide input on submission timelines in co

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