Are you a detail-oriented and organized individual looking for a challenging role in clinical research? 🌐 Novotech is hiring for the role of Clinical Document Specialist (CDS), and we’re here to share the details with you. 💼
About the Job 🌈
As a Clinical Document Specialist, you will play a critical role in managing Trial Master Files (TMF) and ensuring compliance with regulatory requirements. You will work closely with clinical teams to provide support for TMF activities and maintain essential clinical trial documents. If you have a strong background in life sciences and experience in handling TMF activities, this could be the perfect opportunity for you. 📚
Key Responsibilities 📝
- TMF Management: 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.
- Document Uploading and QC Review: Perform document uploading and QC review, ensuring that documents are accurate and complete.
- Client Liaison: Liaise directly with client/alliance partner counterparts with respect to assigned responsibilities.
- Process Improvements: Identify, develop, and lead potential TMF process improvements to drive efficiencies across Novotech.
- Training and Mentoring: Contribute to maintenance and delivery of team training programs and serve as a trainer/mentor to new team members.
Eligibility Criteria 📚
- Education: Minimum Bachelor’s Degree with concentration in Life Sciences.
- Experience: At least 5 years of experience in a clinical research organization or equivalent role.
- Practical Experience: Practical experience in handling Trial Master File activities, including paper or electronic-TMF (eTMF).
- Prior Background: Prior background in the pharmaceutical, CRO, or healthcare industry is advantageous.
Required Skills 📊
- Strong Knowledge of eTMF Systems: Good knowledge of eTMF systems and their applications.
- Attention to Detail: Strong attention to detail and ability to work accurately.
- Communication Skills: Excellent communication and interpersonal skills.
- Team Player: Ability to work in a team and collaborate with colleagues.
How to Apply 📧
If you’re interested in this exciting opportunity, please apply through the below Link 👇🏻:
https://www.linkedin.com/redir/redirect/?url=https%3A%2F%2Fwww%2Eaplitrak%2Ecom%2F%3Fadid%3DcHJpeWFua2Euc2hhcm1hMi4yNzEyMi4xNTUwQG5vdm90ZWNoLmFwbGl0cmFrLmNvbQ&urlhash=XCu6&isSdui=true
Why Novotech? 🌈
- Career Growth: Opportunity to grow and develop your career in clinical research.
- Industry Experience: Gain hands-on experience in a leading clinical research organization.
- Professional Development: Opportunity to contribute to the success of the company and make a difference in healthcare.
Tips for Applicants 📝
- Tailor Your Resume: Make sure your resume highlights your relevant experience and skills.
- Show Enthusiasm: Demonstrate your passion for clinical research and your ability to work in a team.
- Be Prepared: Be prepared to discuss your experience and qualifications.
Conclusion 🌟
Don’t miss this opportunity to join Novotech and contribute to the success of clinical research projects. Apply now and take the first step towards a rewarding career! 🚀
