Senior Document Management Associate

Brief Description The Senior Document Management Associate SDMA will provide support for Trial Master File TMF activities to the clinical teams for all assigned projects This role will be responsible for working with study teams both internal and external to manage both paper and electronic Trial Master Files TMF according to project requirements ICH GCP guidelines local global regulatory requirements and Novotech Client SOPs The SDMA will also be responsible for performing comprehensive QC reviews Minimum Qualifications Experience At least more than 2 years of experience in a clinical research organization or equivalent role 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 Responsibilities 1 Senior DMA will have a dual responsibility of working on document upload and document QC processes 2 Senior DMA will also play an important role in mentoring and training the new DMA team SDMA as a document uploader 1 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 2 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 3 DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements will work with the project team to ensure study documents are of high quality 4 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 5 Performs interim eTMF exports uploads for the sponsor or 3rd party if applicable to the assigned project 6 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 7 Adheres to TMF SOPs KPIs and relevant TMF process-supporting guidance 8 Prepares monthly reports to ensure accuracy of the files and provides to the project teams 9 Prepares the TMF for delivery at study closeout 10 Reviews and prepares the TMF for audits and TMF reviews Provide support to the project team during audits and or regulatory inspections 11 Resolves any internal quality control findings and audit findings 12 Runs and maintains department reports 13 Creates checklists and daily quality control schedules 14 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 15 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 16 Participate in activities of the Clinical Operations department including attendance at company departmental meetings and contributing to the development of clinical processes and SOPs 17 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 SDMA as a QC reviewer 1 Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review 2 Ensure all assigned project QC review are performed after every quarter or as per the study plan 3 Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries 4 Senior DMA will ensure that all queries are responded within the stipulated timeline 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 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 1 Senior DMA will have a dual responsibility of working on document upload and document QC processes 2 Senior DMA will also play an important role in mentoring and training the new DMA team SDMA as a document uploader 1 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 2 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 3 DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements will work with the project team to ensure study documents are of high quality 4 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 5 Performs interim eTMF exports uploads for the sponsor or 3rd party if applicable to the assigned project 6 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 7 Adheres to TMF SOPs KPIs and relevant TMF process-supporting guidance 8 Prepares monthly reports to ensure accuracy of the files and provides to the project teams 9 Prepares the TMF for delivery at study closeout 10 Reviews and prepares the TMF for audits and TMF reviews Provide support to the project team during audits and or regulatory inspections 11 Resolves any internal quality control findings and audit findings 12 Runs and maintains department reports 13 Creates checklists and daily quality control schedules 14 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 15 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 16 Participate in activities of the Clinical Operations department including attendance at company departmental meetings and contributing to the development of clinical processes and SOPs 17 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 SDMA as a QC reviewer 1 Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review 2 Ensure all assigned project QC review are performed after every quarter or as per the study plan 3 Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries 4 Senior DMA will ensure that all queries are responded within the stipulated timeline Qualifications Minimum Qualifications Experience At least more than 2 years of experience in a clinical research organization or equivalent role 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 has offices in 11 geographies across the region and site partnerships with key medical institutions 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 Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands Novotech and PPC Novotech is a clinical CRO with labs phase I facilities and drug development consulting services It has accumulated experience in over 3 700 clinical projects including Phase I to Phase IV clinical trials and bioequivalence studies Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally As of September 30 2021 Novotech had over 2 750 FTEs across 11 geographies in Asia-Pacific the United States and the UK