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11 Novotech Jobs
Document Management Associate
Novotech
·
1-5 years
₹ 4.45 - 5.5L/yr (AmbitionBox estimate)
This is an estimate of the average salary range for this
position. It has not been reviewed by the company, and
the actual salary may differ.
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Document Management Associate
Novotech
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Document Management Associate (DMA)
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.
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.
Responsibilities
- Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according to 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.
- 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.
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.
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.
Employment Type: Full Time, Permanent
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What people at Novotech are saying
Rating based on 2 Document Management Associate
reviews
Anonymous · Research & Development
in Bangalore / Bengaluru
Likes
Flexible working, job security
- Job security - Good
Dislikes
Low salary, insufficient management, no personal growth
- Skill development - Poor
+1 more
Document Management Associate salary at Novotech
reported by
10
employees
with 1-5
years exp.
Unlock
₹4.3
L/yr - ₹5.5
L/yr
49%
more
than the average Document Management Associate Salary in India
View more details
What Novotech employees are saying about work life
based on 63 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novotech Benefits
View more benefits
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