Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
Emmes Group is a global leader in clinical research, driven by a mission to improve patient outcomes and advance innovation in healthcare. With over 47 years of expertise in the field, Emmes serves both public-private partnerships and commercial biopharma, specializing in areas such as cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Currently, they are looking for passionate and detail-oriented professionals to join their team as an Associate TMF (Trial Master File) Specialist at their Bengaluru office. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
Quick Overview for Job Seekers
| Position | Qualifications | Experience | Salary | Location |
|---|---|---|---|---|
| Associate TMF Specialist | Bachelor’s degree (preferably in a scientific discipline) | 0-3 years in clinical operations & TMF filing | ₹6-7 LPA | Bengaluru |
Interview Date: September 29, 2024
Why Should You Consider This Role at Emmes?
Emmes Group is not just a company – it’s a mission-driven organization dedicated to shaping the future of clinical research. By working here, you will have the opportunity to contribute to groundbreaking medical studies and advance your career in an organization known for its excellence in clinical research.
As an Associate TMF Specialist, you’ll be a crucial part of the team responsible for managing the Trial Master File (TMF), a vital component in clinical trials. This position offers freshers and professionals with up to 3 years of experience a chance to work in a fast-paced and evolving environment while learning the ins and outs of clinical research documentation and compliance. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
What is a Trial Master File (TMF)?
Before diving into the responsibilities of the role, let’s break down what a TMF is and why it’s essential in clinical research.
The Trial Master File (TMF) is a collection of essential documents that allows clinical trials to be conducted smoothly and ensures the validity and integrity of the data. A well-organized TMF is essential for demonstrating that a clinical trial follows regulatory standards and Good Clinical Practices (GCP) guidelines. The TMF serves as evidence of the trial’s conduct, compliance with protocol, and adherence to regulatory obligations. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
At Emmes, you will work with an electronic Trial Master File (eTMF) system, a digital solution for managing the TMF, streamlining document collection, and ensuring proper filing and organization in compliance with industry standards.
Primary Purpose of the Associate TMF Specialist Role
The Associate TMF Specialist will be responsible for uploading, indexing, and maintaining TMF documents within the eTMF system. You will ensure that the TMF complies with Standard Operating Procedures (SOPs), ICH/GCP guidelines, and TMF best practices. Moreover, you will play a critical role in ensuring the successful execution of clinical trials by maintaining accurate, up-to-date documentation. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
Key Responsibilities
As an Associate TMF Specialist, your responsibilities will include the following:
1. Acting as a Subject Matter Expert (SME)
You will serve as an SME on eTMF features related to TMF operations. This includes overseeing the proper filing of documents and ensuring that all processes align with the TMF Plan or Index. Your understanding of the TMF system will help streamline operations and ensure documents are correctly managed throughout the trial process.
2. Ensuring Compliance with GCP and TMF Guidelines
You’ll ensure that all TMF documents are collected, indexed, and stored in compliance with Good Clinical Practice (GCP) guidelines, the TMF Reference Model, and other industry standards. Adhering to these guidelines is crucial to ensure that clinical trials are conducted ethically and according to regulatory requirements. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
3. Contributing to SOP Development
You will assist in the creation and refinement of Standard Operating Procedures (SOPs) to ensure the efficient and effective management of TMF processes. This will include collaborating with quality control (QC) and quality assurance (QA) teams to identify areas of improvement and streamline the TMF lifecycle.
4. Supporting Veeva Vault eTMF System Implementation
Working closely with the Clinical Systems Manager, you’ll help implement features of the Veeva Vault eTMF system, a widely used electronic system in the clinical research industry. This will involve assisting with system enhancements, troubleshooting, and ensuring that the system meets the needs of ongoing clinical trials.
5. Participating in Process Automation
Automation is transforming how clinical trials are managed. You will have the opportunity to contribute to process automation efforts, including the use of VBA macros, Robotic Process Automation (RPA), and emerging technologies like AI/ML. These tools will help improve efficiency and accuracy in TMF management. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
6. Maintaining the TMF Lifecycle
Your role will also include monitoring the TMF lifecycle, from initial document creation to final archiving. This involves generating reports, tracking documents, and ensuring that everything is up to date and accurate. You’ll play a key role in ensuring that the TMF is audit-ready at all times.
Key Qualifications
To be considered for the Associate TMF Specialist role, you will need to meet the following qualifications:
- A Bachelor’s degree, preferably in a scientific discipline, is required.
- 0-3 years of experience in Clinical Operations and TMF filing.
- Experience working with eTMF applications and document filing procedures. Familiarity with the Veeva Vault eTMF system is a plus.
- Strong organizational, planning, analytical, and problem-solving skills.
- Knowledge of Good Clinical Practice (GCP) guidelines, TMF regulations, and the TMF Reference Model.
- Experience with NIH-sponsored clinical programs is a bonus but not mandatory.
- Ability to work in a fast-paced, high-pressure environment and manage competing priorities.
- Excellent communication skills and fluency in English are required.
Skills & Competencies
To succeed in this role, you should possess the following skills and competencies:
- Attention to detail: The TMF is a highly regulated and critical component of clinical trials, so accuracy and attention to detail are essential.
- Relationship-building: You will need to build positive relationships with your team and management to ensure smooth operations and foster a collaborative work environment.
- Self-motivation: Being proactive and results-driven will be key to your success. Emmes values individuals who take initiative and consistently strive for excellence. Fresher Needed Emmes Group Hirinf for Associate TMF Specialist
Why Work at Emmes?
1. Global Leader in Clinical Research
Emmes Group has a reputation for excellence and innovation in clinical research. Working here means you’ll be part of an organization that is shaping the future of medicine and advancing patient care.
2. Opportunities for Career Growth
At Emmes, there are abundant opportunities for professional growth. Whether you’re just starting your career or looking to take the next step, Emmes provides a dynamic environment with continuous learning opportunities.
3. Competitive Salary
With a salary range of ₹6-7 LPA, the role offers a competitive package, especially for freshers and those with up to 3 years of experience. Additionally, working in Bengaluru, a hub for clinical research, means access to numerous opportunities for future growth.
4. Work-Life Balance
Emmes places importance on employee well-being, offering flexible working conditions and fostering a culture that values time management and work-life balance.
How to Apply
Interested candidates can apply for the Associate TMF Specialist position by submitting their resume and credentials to Emmes. This is an excellent opportunity to kickstart or advance your career in the clinical research industry.
Application Link
Don’t miss the chance to join a leader in the field of clinical research and contribute to the advancement of medical science!