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Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications with various vendors Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks),....

Job Description Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilitiesWorks to ensure adherence to a standardized approach to project managementManages clinical trials projects through leadership of and delegation to a cross-functional study execution team, Ensures successful clinical trial planning, execution and delivery – within specified quality, time....

SPECIFIC JOB DESCRIPTIONKEY ACCOUNTABILITIESImplements, conducts or monitors on-site clinical trials.Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas.Leads own team of....

Responsible for Pharmacovigilance Operations activities for all safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with....

As Head of Quality, this position will be responsible for driving a comprehensive quality strategy and quality system for the company. Working with the company senior leadership and line function heads to define an overarching quality strategy, systems and culture that is applicable to the activities that occur within the company. That will allow the basis to structure/build the group necessary to execute on the agreed upon strategy.Activities include management and GMP oversight of product,....

We are looking for Clinical Study Leads to help us initiate and manage Ph I-II, global and/or domestic oncology trial(s). The position will be responsible for planning, implementing and managing trials, working as part of a dynamic clinical development team. If you enjoy a start up environment and are looking to contribute to a very talented clinical team, we are the company for you. For the right person, we are flexible with title for the position and will consider Senior Manager through....

Job Summary Head the Quality function at Akebia. Responsible for the development, implementation, and administration of the Quality Management System (QMS) including activities, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. Activities include management and oversight of product development, testing, stability, validation data, documentation, and records relating....

Roles and ResponsibilitiesFormulate, establish and maintain policies and procedures and accompanying system related to cGMP, GCP and GLP compliance with global regulatory requirements.Establish and maintain an overall Quality System to support Phase 3 and commercial cGMP activities.Manage document control and training systems.Establish and maintain systems for vendor qualifications and audits for GXP activities.Lead preparations for and manage preapproval and routine regulatory agency....

OBJECTIVES: Execution of clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and Takeda SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP). Leadership of the cross functional Study Execution Team (SET), including Takeda functions, Strategic Partners and other vendors, to ensure study objectives are met, on time and within budget.....

Roles and ResponsibilitiesAs a member of the program teams, provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.Manage and ensure compliance with all reporting requirements, including annual and periodic reports.Organize and manage regulatory meetings with health authorities.Review....