Job title: Analyst, Clinical Quality Systems
Company: Baxter Medical Devices
Job description: This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission. Summary: This section focuses on the main purpose of the job in one to four sentences. Responsible for supporting the Sr Principal, Quality Associate in the administration and maintenance of the Baxter Clinical Trial Master File (TMF). The TMF serves to demonstrate compliance of the sponsoring company (i.e. Baxter) and the clinical investigators involved in the clinical trial with the standards of Good Clinical Practice (GCP) and applicable regulatory requirements in the region where the clinical trial is conducted. This job includes assisting with essential study document management, organizing the trial master file (TMF), administrating the electronic TMF (eTMF) system, training users how to use the eTMF, organizing paper TMFs, and preparing documentation for audits and regulatory submissions. The job also involves collaboration with members of the clinical project team such as the clinical project manager and clinical researchers within a contract research organization (CRO) to gather study information, collect study documents, assess the completeness and accuracy of study documents, organize clinical data reports, and request updates from team members. Operation of the eTMF involves manually entering information about the document into the system after reviewing and classifying the study document, following a record index to know where to file a document within the eTMF, and performing quality control review of the completeness and accuracy of the information on the document. This position reports directly to the Sr Principal, Quality Associate within the Global Clinical Quality organization, who is stationed in Chicago (USA). Essential Duties and Responsibilities: This includes but is not limited to: Serve as a primary user of the electronic Trial Master File (eTMF) system which involves uploading, indexing, and entering metadata for essential study documents into the correct eTMF filing structure, and performing a quality check of document accuracy for each clinical trial that Baxter sponsors. Assist the Sr Principal, Quality Associate as an administrator for the eTMF system by: Assisting with the initial set up of new studies in the eTMF Providing continual end-user support trouble shooting and issue escalation of the eTMF system Maintaining security and change management of the eTMF, including documentation, notification, and adherence to applicable processes and SOPs Back-up for conducting role-specific and ad hoc training of eTMF for members of the Global Clinical Development organization Documenting eTMF/CTMS system training records and sending to quality teams for record keeping Assist in managing paper TMF records by: Shipping and receiving, organizing, and filing paper TMF documents, including site documents, email correspondence, training materials and other study documents in the appropriate secure filing locations. Coordinating receipt of shipments and electronic transfers of clinical study documents from TMFs held outside of Baxter when study management is outsourced to a CRO or when Baxter acquires other companies. Assessing completeness of the TMF for a study based on the file management plan or TMF index of required documents. Participate in audit-readiness activities such as document review/auditing, document reconciliation, and collaborating with the clinical operations team to close gaps in documentation Collaborating with Clinical Operations, Data Management, and Statistics for management of study records and other records management activities Request missing documents for the TMF from cross-functional team members such as the data management plan and statistical analysis plan Prioritize work and schedule to align with business needs when applicable. Support maintenance of Records Management SharePoint site Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Knowledge, skills, and/or abilities required listed below. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. This position requires familiarity with computer software maintenance and testing Experience working with an electronic trial master file (TMF) system is preferred Experience with related clinical systems such as CTMS, EDC, Clinical Supply systems, and SharePoint is desirable. Meticulous attention to detail, an eye for quality when reviewing documentation, ability to understand directions and follow those directions after receiving training, and ability to work effectively both as an independent contributor and as a member of the team are expected for this position. Must be able to ask good questions to obtain information and learn from the information that is taught. Ability to identify GCP compliance risks and escalate when necessary. Excellent verbal and written communication, presentation, interpersonal and organizational skills are required. Must speak and read English fluently and be able to communicate and collaborate via email and phone calls with team members around the world. Must be able to read and compared user manuals/instructions for how to use the eTMF. Experience with CSV, Microsoft Excel, Word, PowerPoint, HTML, and NotePad, file types is required. Ability to maintain effectiveness under changing circumstances and priorities. Must be able to expand knowledge and adapt to an increasingly complex environment. Education and/or Experience: Bachelor’s degree required. Plus 2 years’ relevant work experience in: Working at a healthcare company or pharmaceutical or medical device working as a clinical researcher, working with computer systems at a research company, laboratory, research institution, or hospital in medical office management or as a technical assistant. Must also have experience: Working with cross-functional teams. Familiarity with the DIA Trial Master File Reference Model is preferred. Familiarity and ability to comply with international good clinical practice (GCP) guidelines, government regulations, and standard operating procedures related to clinical research and development of pharmaceuticals and medical device products is preferred. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our . 067150
Expected salary:
Location: Bangalore, Karnataka
Job date: Fri, 17 Jun 2022 22:21:19 GMT
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