Senior Document Management Associate
About the Role
Company Overview
Novotech is a global clinical research organization. It helps biotechnology and pharmaceutical organizations conduct clinical trials and regulatory services. It conducts its operations around the world, including in North America and Europe.
Novotech integrates local knowledge with global competencies. It provides clinical research that is of high quality and meets all regulations. Novotech is renowned for its high standards and client orientation.
It provides an enabling and collaborative work culture. The employees have chances to conduct global studies. It ensures learning and growth for its employees.
Job Description
The Senior Document Management Associate will be in charge of Trial Master File (TMF) activities relating to the clinical trials. This will involve managing paper as well as electronic TMFs as per the:
ICH-GCP
Regulatory, and
Internal policies and procedures
The best candidate should work with the clinical trial team, sponsors, and other stakeholders within the company to ensure that all documents related to the clinical trials are accurate, complete, and auditable.
Key Responsibilities
Responsibilities include overseeing the process of setting up, tracking, and maintaining TMFs for assigned projects. This position entails receipt of:
Study documents
Assessing completeness of documents, and
Ensuring proper filing
This is done either electronically or physically in TMFs with the use of tools such as SharePoint.
This position involves uploading, scanning, tracking, and organizing documents. This should be done according to standards of practice and regulatory guidelines. It ensures the documentation process is done in an efficient manner that keeps the TMF ready for inspections during the course of the study.
This position involves conducting quality control checks on the documents to verify correctness and completeness of the documents according to the critical document requirement.
Report preparation regarding the status of the document, its quality, and timeline of collection will be done by the individual. They will provide updates to the study teams, ensuring completeness of all documentation.
The individual will also prepare TMF in case of audits, regulatory inspections, and closure of the studies. Support during audit activities and any findings in case of quality will be done by the candidate.
The candidate will perform periodic QC review of the projects under their purview. They will prepare QC checklists and follow-up queries related to the project.
Training of junior team members and mentoring will also be one of the responsibilities of the individual. They will help in transferring knowledge and keeping uniformity in the documentation process.
Moreover, the candidate will help in process improvement, maintaining departmental reports, and participation in clinical operations activities.
Qualification and Skill Requirement
Education- Bachelor’s degree in:
Life Sciences
Pharmacy, or
Related field
Experience- 2+ years in a clinical research organisation or similar environment
Hands-on experience in managing Trial Master Files, even with electronic Trial Master Files, is mandatory.
This job needs extensive knowledge of ICH-GCP guidelines and clinical documentation guidelines. Hands-on experience with Paper and Electronic Trial Master Files is desirable.
Attention to detail and good organizational skills are highly desired in candidates.
Candidates need to have good multitasking and deadline skills.
Effective communication and teamwork skills are needed. Interaction skills to work with cross-functional teams and outside stakeholders.
Document Management systems like SharePoint and basic Microsoft Office are mandatory.
Salary and Benefits
Novotech provides competitive compensation packages that match industry standards. The pay package in this job is anywhere between ₹5-6.5 LPA. Any negotiation based on experience and expertise can be carried out.
Flexible working conditions and wellness programs are some of the perks enjoyed by employees at Novotech. Professional development and mentoring programs are other features offered by the company to its employees.
Role Importance and Career Growth
The Senior Document Management Associate is essential in making sure that all documents related to the clinical study are properly managed and are in compliance with all standards. It helps in gaining approvals from regulatory authorities and proper conduct of the clinical study.
The Senior Document Management Associate gives promising career advancement chances for one to become a TMF Lead or a Clinical Project Manager.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Senior Document Management Associate / Novotech.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant education, attention to detail, and any experience in Document Management.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.