OrciMed Life Sciences Hiring TMF Specialist
- OrciMed Life Sciences Hiring TMF Specialist – Clinical Trial Master File Management | Hyderabad
- Company Overview
- Job Role & Responsibilities
- Clinical Trial Documentation Management
- eTMF System Management
- Compliance & Quality Oversight
- Cross‑Functional Collaboration
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Required Skills
- Location & Employment Details
- Application Process
- Frequently Asked Questions (FAQs)
- 1. Who can apply for the TMF Specialist role at OrciMed Life Sciences?
- 2. Is Phlex TMF experience mandatory?
- 3. Is this role suitable for freshers?
- 4. What career growth opportunities exist in TMF management?
- 5. What type of organization is OrciMed Life Sciences?
- Recruitment Summary
OrciMed Life Sciences Hiring TMF Specialist – Clinical Trial Master File Management | Hyderabad
OrciMed Life Sciences is currently hiring a TMF Specialist for its clinical research operations team in Hyderabad, India. This opportunity is designed for professionals with a minimum of 2 years of Trial Master File (TMF) experience who have hands-on exposure to Phlex TMF systems and clinical trial documentation management.
The role sits within the clinical research documentation and regulatory compliance function, where the TMF Specialist ensures that essential clinical trial documents are properly filed, tracked, and maintained according to regulatory standards. Candidates who are experienced in clinical trial documentation, eTMF systems, and CRO operational workflows will find this role well aligned with long‑term career growth in clinical operations and regulatory documentation management.
Professionals who can join immediately will be given preference as the team is expanding its TMF operations to support ongoing global clinical research projects.
Company Overview
OrciMed Life Sciences is a specialized clinical research and life sciences services organization that supports pharmaceutical, biotechnology, and healthcare companies across multiple stages of drug development. The company focuses on delivering high‑quality operational and documentation support to clinical trial teams while maintaining strict compliance with global regulatory requirements.
In the modern clinical development environment, accurate documentation and proper management of essential trial records are critical. Clinical Trial Master File (TMF) management ensures that all documents related to study conduct, regulatory approvals, investigator communication, and operational activities are maintained in accordance with ICH‑GCP guidelines and regulatory inspection standards.
Organizations like OrciMed play a crucial role in supporting sponsors and CRO partners by ensuring the integrity, completeness, and accessibility of clinical trial documentation. Through structured documentation systems, TMF specialists contribute directly to regulatory inspection readiness and overall study compliance.
Job Role & Responsibilities
The TMF Specialist is responsible for maintaining the completeness, accuracy, and regulatory compliance of the electronic Trial Master File (eTMF) throughout the lifecycle of clinical trials.
Clinical Trial Documentation Management
- Maintain and organize Trial Master File documentation according to regulatory requirements and company SOPs.
- Ensure all essential clinical trial documents are accurately filed in the Phlex TMF system.
- Perform regular quality checks to ensure documents meet regulatory and inspection standards.
- Track missing or incomplete documents and follow up with relevant stakeholders.
eTMF System Management
- Upload, classify, and index study documents within the electronic TMF system.
- Maintain document version control and ensure proper metadata tagging.
- Support document reconciliation activities during study milestones.
- Ensure documentation structure aligns with regulatory frameworks and study protocols.
Compliance & Quality Oversight
- Ensure all TMF activities comply with ICH‑GCP, regulatory authority guidelines, and sponsor requirements.
- Support internal quality checks and audit preparation activities.
- Maintain documentation readiness for regulatory inspections.
Cross‑Functional Collaboration
- Work closely with Clinical Operations, Regulatory Affairs, and Project Management teams.
- Coordinate with clinical research associates and study teams to ensure timely document submission.
- Assist project teams with documentation tracking and reporting.
This role requires strong attention to detail, documentation accuracy, and knowledge of clinical trial documentation structures.
Eligibility / Qualifications
Educational Qualification
Bachelor’s degree in Life Sciences or related healthcare discipline.
Relevant Courses: B.Pharm, M.Pharm, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Biomedical Sciences, Pharmacy Practice, Healthcare Management.
Experience
- Minimum 2 years of relevant TMF experience (mandatory).
- Experience working in clinical research organizations (CROs) or pharmaceutical companies is preferred.
Required Skills
- Hands‑on experience with Phlex TMF system (mandatory).
- Strong understanding of Trial Master File structure and essential clinical trial documents.
- Familiarity with ICH‑GCP guidelines and clinical research documentation standards.
- Ability to manage large volumes of clinical documents accurately.
- Strong organizational and documentation management skills.
- Proficiency in MS Office tools such as Excel, Word, and PowerPoint.
- Excellent written and verbal communication skills.
Candidates who demonstrate strong documentation discipline and regulatory awareness will be well suited for this role.
Location & Employment Details
Location: Hyderabad, India
Job Role: TMF Specialist
Employment Type: Full‑Time
Application Process
Interested candidates can apply by sending their updated resume to the email address below:
careers@orcimedlifesciences.com
Applicants are encouraged to highlight their TMF management experience, Phlex TMF system expertise, and clinical trial documentation skills in their resumes.
Candidates who are available for immediate joining will receive preference during the selection process.
Frequently Asked Questions (FAQs)
1. Who can apply for the TMF Specialist role at OrciMed Life Sciences?
Candidates with a life sciences degree and at least 2 years of TMF experience in clinical research can apply.
2. Is Phlex TMF experience mandatory?
Yes. Hands‑on experience with the Phlex TMF platform is mandatory for this role.
3. Is this role suitable for freshers?
No. The position requires a minimum of two years of relevant TMF experience.
4. What career growth opportunities exist in TMF management?
Professionals can progress into TMF Lead, Clinical Documentation Manager, Clinical Operations Specialist, or Regulatory Operations roles.
5. What type of organization is OrciMed Life Sciences?
OrciMed Life Sciences is a clinical research services organization supporting pharmaceutical and biotechnology companies with clinical trial operations and regulatory documentation management.
Recruitment Summary
| Company | OrciMed Life Sciences |
|---|---|
| Vacancies | TMF Specialist |
| Required Education | Bachelor’s Degree in Life Sciences or Related Field |
| Experience | Minimum 2 Years TMF Experience with Phlex TMF |
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