Novotech hiring Document Management Associate

Document Management Associate

Brief Position Description:

The Clinical Document Management Associate (CDMA) 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.

Minimum Qualifications & Experience:

Minimum bachelor’s degree with concentration in Life Sciences and experience within Pharmaceutical Industry. 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.

Responsibilities:

• Will receive all study documentation for assigned projects; CDMA will set up, receive, track and maintain electronic or paper TMFs according to 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.

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.

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