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IQVIA

Runs drug trials and sells health data to pharma

TMF Document Specialist

Office Clerical & RecordsConfirmed live in the last 24 hours
Full-timeDalian, Liaoning, ChinaNo salary listedIn-person

About the Job

Requirements

  • High school diploma or equivalent.
  • Three to four years of experience working in a relevant clinical research environment; an equivalent combination of education, training, and experience may qualify.
  • Good knowledge of applicable clinical research regulatory requirements, including 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.
  • Good command of English, including oral and written communication skills.
  • Ability to manage and lead others.
  • Ability to establish and maintain effective working relationships with internal and external clients.
  • Ability to perform significant writing and keyboarding involving repetitive finger motions and prolonged sitting.
  • Ability to stand, walk, sit, use hands to manipulate, handle, or feel, and reach with hands and arms.
  • Ability to stoop and kneel, and potentially use a ladder to access paper files on high-density file systems.
  • Ability to lift objects up to 40 pounds (18 kilograms) without assistance.
  • Willingness to work shifts if required.

Responsibilities

  • 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 according to project plans.
  • Coordinate retrieval of records requested by users and prepare closed studies for delivery to their final destination within agreed timelines.
  • Conduct and manage scanning processes and train staff on those processes.
  • Interface with departments to support retrieval projects and ensure information needs are met.
  • Serve as the primary contact for internal and external clients.
  • Monitor and review filing accuracy and compliance with IQVIA or customer file plans and Standard Operating Procedures (SOPs), where applicable.
  • Maintain records center security and protect record integrity by ensuring compliance with SOPs.
  • Coordinate transfer, recall, and disposition of records to commercial records storage centers, as needed.
  • Oversee disposal of obsolete records and maintain records storage space, supplies, and equipment efficiently.
  • Train team members on records management tasks, policies, and procedures.
  • Establish and maintain effective communications with internal and external clients.
  • Design and administer records management systems and processes.
  • Ensure project deadlines, commitments, and goals are met by monitoring daily project outputs.
  • Function as team leader for records management projects, as needed.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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