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Senior CRA

Job Description: OVERVIEWUtilizing CSRs, prepare results from a number of therapeutic areas, in the Clinical Trial Results format, for submission to the EMA's results website,EudraCT.Circulate the prepared results for review by key clinical team members, addressing team questions, archiving the approvals and prepared result into the document repository.Prepare and make the submission in EudraCT. Assist the clinical disclosure team with any other support required for meeting the EU backlog of results submission to EudraCT or in facilitating clinical team review of redacted CSRs for voluntary data sharing. Skills: Must have a minimum of 10 years clinical research and development experience,…

Project Manager, Site Activation Services (435055)

Job Description: Overview:As a member of our Study Startup team you will work across diverse therapeutic areas, providing your expertise and leadership to coordinate and direct operational delivery to achieve business and client objectives. We recognizes the importance of having professionals dedicated to the startup stages of studies, and we have a committed Study Start-Up team utilizing innovative technology. Responsibilities/Duties:Lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director.Ensure…

Business Operations Manager (435108)

Job Description: OVERVIEWContractor will provide comprehensive decision support and help build financial processes around reporting, planning, analytics, and operations. This contractor position will be responsible for delivering value-added business analyses as well as defining and reporting meaningful financial and operational metrics that lead to insightful, accurate business decision-making.This position will liaise with Clinical Trial Mangers, Clinical Contracts & Outsourcing Manager, Financial Planning & Analysis and the Accounting department to provide operational and decision support to Senior Clinical Management.This position will play a key role in developing and implementing standard financial processes including month-end and daily operations.Essential Functions:Provide support for the…

Study Data Manager (435112)

Job Description: OVERVIEW Acts as a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams. Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies. Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met.Performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing…

Clinical Research Associate II (435113)

Job Description: OVERVIEWResponsible for the conduct and management of post marketing commitment studies, focusing in the areas of protocol development, study planning and implementation, site monitoring and management, enrollment and data quality.Responsible for feasibility assessments for new studies.Manages TMF contents and responsible for TMF reconciliation.Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.).Responsible for the preparation of study training and investigator meeting materials and presents at study training workshops and investigator meetings.Responsible for the development and preparation of study start-up, maintenance, and close-out activities, including monitoring plan.Responsible for the adherence to timelines, study quality and SOPs…

Global Statistical Analyst (435296)

Job Description: Overview:The Global Statistical Analyst (GSA) is a key role within Global Biostatistics (GBS) to ensure operational and execution excellence. The GSA mainly provides efficient implementation of statistical strategy and maintains standards (e.g. CDISC) for regulatory submissions and interactions with regulatory authorities across therapeutic areas.The GSA works closely with Global Statistical Scientists (GSS) and clinical program teams across therapeutic areas. The GSA may also act as a surrogate for the GSS for particular clinical programs as requested. The role of GSA requires broad statistical knowledge and excellent operational skills. This role has global responsibilities and interacts with global teams.…

SAS Programmer (428395)

Job Description: OVERVIEW Requirements • Working knowledge of SAS, familiar with SAS/GRAPH, and SAS/MACRO • Production of statistical reports and the programming of tables, listings and figures • Detailed understanding of industry standards for database design (CDISC: SDTM, ADaM) • Excellent analytical, problem solving, communication and organization skills with the ability to work simultaneously in multiple tasks and teams • Ability to work in a collaborative environment, drive to learn and improve skills • Ability to communicate statistical interpretation to non-scientists Key Accountabilities • Produce tables, figures and data listings using efficient programming techniques • Perform statistical analyses under close…

Trial Supplies Operations Manager

Job Description: OVERVIEWThe Trial Supplies Operations Manager is responsible for the implementation of appropriate Clinical Supplies strategies and processes in order to achieve clinical study objectives in assigned programs. Responsibilities Include: Receives the Extended Synopsis/protocol and will provide feedback /comments to Project leaders and Clinical teamsObtain detail information about Clinical trials assigned including IP design, countries, blinded or open label trials, distribution strategy and other details.Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials.Monitoring patient recruitment and adjust the resupply strategy as needed.Work in collaboration with internal and external stakeholders…

Sr. Validation Specialist/ Sr. Engineer

Job Description: Azzur Group CA is seeking a Sr. Validation Specialist/Sr Engineer. In this role, you will be responsible for performing equipment, cleaning, and process and/or facilities validation. Essential Duties and Responsibilities · Performs/ executes/ validates (IQ, OQ, PQ) for Equipment, Cleaning and Facilities Validation and Computer System Validation (CSV). · Writes, and executes protocols, reviews and analyzes study data, writes summary/final reports. · Writes, reviews and revises a variety of installation, operation and performance qualification/ verification related documents. · Writes reports to summarize validation/verification/commissioning and/or re-validation/ verification/commissioning activities. · Supports the resolution of regulatory observations or manufacturing site issues.…

Senior Clinical Research Associate/ Lead CRA (440583)

Job Description: OVERVIEW: • Responsible for the execution of a clinical study or studies in one or more Clinical Programs. • Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and Client's Standard Operating Procedures (SOP) • Oversees the work of the clinical research associates (monitors) who are assigned to a study managed by the SCRA. • Assumes leadership role for one or more clinical studies; serving as primary clinical contact for a study including CROs/vendors, Investigators, study coordinators, study nurses, and administrators • May develop clinical protocols, informed consent forms, or…