• Associate , Clinical Systems Support for eTMF and Records Management Jobs in Bangalore,India - 25095227

  • Baxter India Pvt Ltd

Job Description:

This section focuses on the main purpose of the job in one to four sentences

Responsible for supporting the Associate Director of Clinical Systems in the maintenance of the Baxter Clinical Trial Master File (TMF) and organization of clinical study records and documents A TMF is a set of electronic or paper records that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced by the clinical trial The TMF serves to demonstrate compliance of the sponsoring company (ie 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 communicating weekly/bi-weekly via email and occasionally phone 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 positon reports directly to the Associate Director of Clinical Systems within the Global Clinical Development 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 Clinical Systems Associate Director 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 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, IVRX, 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

Bachelors 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

Equal Employment Opportunity

Baxter is an equal opportunity employer Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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 Americas_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 12th May 2020

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