Job Overview
Provide Trial Master File (TMF) related assistance to study teams.
Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems.
Essential Functions
• Perform assigned complex administrative tasks to support team members with project execution
• Assist in updating and maintaining complex data in systems within project timelines and per project plans
• Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines
• Conduct and manage scanning processes and train staff on scanning processes
• Interface with departments to support retrieval projects and ensure information needs are met
• Serve as primary contact for internal/external clients
• Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable
• Maintain records center security to protect record integrity by ensuring compliance to SOPs
• May coordinate transfer, recall, and disposition of records to commercial records storage centers
• Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
• Train team members on records management tasks, policies, and procedures
• Establish and maintain effective internal and external client communications
• Design and administer records management systems and processes
• Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
• May function as team leader for records management projects
Qualifications
• High School Diploma or equivalent Req
• 3-4 years’ experience working in revelant clinical research environment. Equivalent combination of education, training and experience.
• Good knowledge of applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines;
• Knowledge of technology applications relevant to records center environments.
• General knowledge of computer technology and software programs, and accurate data entry skills.
• Attention to detail and accuracy in work.
• Ability to achieve productivity despite time pressure constraints.
• Good problem solving skills.
• Strong organizational, planning, and decision making skills.
• Good time management and prioritization skills.
• Extensive knowledge of records management laws and regulations.
• Excellent oral and written communication skills including good command of English language.
• Ability to manage and lead others.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
• Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.
• Position is required to stoop, kneel and may need to utilize a ladder for paper files on high-density file systems.
• Unaided lifting of objects up to 40 pounds/18kgs.
• May require to work in shifts.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
br{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Job description Should be having minimum 3 years of experience with excellent level of proficiency...
Apply For This JobFull Job Description Job Requirement: HRVacancy: Human Resources RecruitmentDesignation: HR AnalystJob Location: Bangalore South ZonePay Scale: As Per Industry Standard...
Apply For This JobFull Job Description Job Description Senior Financial Analyst is responsible for providing proactive visibility of financial performance while serving as...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Hiring Accounts Assistant for Pharma Export Company. Share resume on email id RNMCONSULTANTS at GMAIL.COM....
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Hiring BDE (BUSINESS DEVELOPMENT EXECUTIVE) * Generating sales for Edutech company * Cold calling *...
Apply For This JobJob Location: Mumbai (Bombay), Karjat Job Description: SITE ENGINEER WILL BE RESPONSIBLE FOR ENTIRE COORDINATION BETWEEN DIFFERENT AGENCIES AT SITE...
Apply For This Job