Allucent™ is a dynamic and innovative firm dedicated to empowering small-to-medium biopharmaceutical companies as they navigate the complexities of clinical trials. Our mission is to facilitate the development of life-changing therapies that reach patients in need globally. We believe in fostering a collaborative environment that values quality, compliance, and excellence.
Job Description: TMF Specialist I
Allucent is currently seeking a TMF Specialist I to join our A-team in Bengaluru, Karnataka (Hybrid Role). This role is pivotal in supporting the Trial Master File (TMF) management process, ensuring that documents are accurately indexed and compliant with regulatory standards.
Key Responsibilities:
- Review documents to ensure compliance with Good Document Practices and ALCOA+ standards.
- Confirm the categorization of documents per the DIA reference model and Allucent TMF Index.
- Assess document metadata in the Veeva Vault system for compliance with study-specific instructions.
- Identify and communicate any issues with documents that do not meet required standards.
- Track trends in poor document completion and escalate them to the TMF Manager and TMF Lead.
- Participate in team meetings for continuous improvement of TMF documentation practices.
- Mentor junior TMF Specialists and support team learning and development.
- Act as a Subject Matter Expert (SME) for TMF processes, contributing to quality system improvements.
- Maintain effective communication and relationships with potential and existing clients.
- Engage in client evaluations and visits.
Requirements:
To be successful in this role, candidates should have:
- A degree in life sciences, healthcare, or business.
- A minimum of 2 years of relevant experience handling documents within the TMF.
- At least 2 years of experience in drug development or clinical research.
- Proficiency in GCP, GDPR/HIPAA, CRF, CTR, and relevant regulatory requirements.
- Extensive knowledge of clinical trial documentation and the DIA TMF reference model.
- Excellent written and verbal communication skills in English.
- A client-focused attitude with strong interpersonal skills.
- Ability to thrive in a fast-paced environment.
- Administrative excellence and attention to detail.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
Benefits of Working at Allucent
- Comprehensive benefits package tailored to your location.
- Competitive salary.
- Departmental budget for professional development training.
- Flexible working hours and hybrid work opportunities.
- Leadership and mentoring potential.
- Participation in our Buddy Program for seamless onboarding.
- Internal growth opportunities for career advancement.
- Financially rewarding employee referral program.
- Access to online training resources (GoodHabitz and more).
- Eligibility for Spot Bonus and Loyalty Award Programs.
