Document management association Openings – CRO / Clinical Research

Novotech Looking for Document Management Associate for pharmaceutical, CRO or healthcare industry Candidates

Job Responsibilities:

• Will receive all study documentation for assigned projects; CDMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs.
• CDMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint, paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs.
• CDMA 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.
• CDMA 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 CDMA. Be quality-minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out CDMA 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.

Opportunities and benefits:

• Novotech is proud to offer a great workplace.
• Novotech 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.
• 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.