Document Management Associate

Novotech

  • India
  • Permanent
  • Full-time
  • 1 day ago
Job Description:About The Role:The Document Management Associate (DMA) will provide support for Trial Master File (TMF) activities to the clinical teams. This role will be responsible for working with study teams, both internal and external, to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs.Responsibilities:
  • Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs.
  • DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs.
  • DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality.
  • DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner.
  • Ensure the TMF is 'inspection ready' at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines.
  • Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
  • Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project.
  • Runs monthly reports to ensure accuracy of the files by performing file reviews.
  • Prepares the TMF for delivery at study closeout.
  • Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections.
  • Resolves any internal quality control findings and audit findings.
  • Runs and maintains department reports.
  • Creates checklists and daily quality control schedules.
  • Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.
  • Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role.
  • Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
  • Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
Minimum Qualifications & Experience:
  • At least 12 months experience in a clinical research organization or equivalent.
  • Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF).
  • Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.Responsibilities:Responsibilities
  • Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs.
  • DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs.
  • DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality.
  • DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner.
  • Ensure the TMF is 'inspection ready' at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines.
  • Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
  • Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project.
  • Runs monthly reports to ensure accuracy of the files by performing file reviews.
  • Prepares the TMF for delivery at study closeout.
  • Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections.
  • Resolves any internal quality control findings and audit findings.
  • Runs and maintains department reports.
  • Creates checklists and daily quality control schedules.
  • Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance.
  • Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role.
  • Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
  • Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
Minimum Qualifications & Experience:
  • At least 12 months experience in a clinical research organization or equivalent.
  • Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF).
  • Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
Qualifications:Minimum Qualifications & Experience:
  • At least 12 months experience in a clinical research organization or equivalent.
  • Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF).
  • Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.
About Us:Novotech is a global full-service clinical Contract Research Organization (CRO).Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.About the Team:At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.At Novotech you will work alongside empowered teams with a shared commitment to success.
  • Strategic vs transactional mindset.
  • Ability to gain insights and make proactive decisions quickly.
  • Culture that fosters partnership and collaboration, where every voice is heard and valued.
  • Ongoing support from senior stakeholders and leadership team.
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Novotech