Job Opportunity: TMF Specialist I – Accelerate Your Career in Clinical Research
Summary:
Allucent, a leading global clinical research organization (CRO) dedicated to helping small and mid-sized biopharma companies accelerate drug development, is seeking a detail-oriented and highly motivated TMF Specialist I to join our dynamic team in Bengaluru, India. This hybrid role offers an exciting opportunity to contribute to the integrity and quality of clinical trial documentation, ensuring compliance with industry regulations and best practices. If you have a strong background in Trial Master File (TMF) management, Good Clinical Practice (GCP), and clinical documentation systems, particularly Veeva Vault, we encourage you to apply.
About Allucent:
At Allucent, we are driven by a shared passion for advancing healthcare and improving patient lives. We partner with innovative biopharma companies, providing a full spectrum of clinical research services, from early-stage development to post-market surveillance. We foster a collaborative and supportive environment where every team member can thrive and make a meaningful impact. Join us and be part of a team that is shaping the future of medicine.
Key Responsibilities:
As a TMF Specialist I, you will play a crucial role in maintaining the integrity and accuracy of our clients’ Trial Master Files. Your responsibilities will include:
- Document Review & Compliance: Thoroughly review clinical trial documents for compliance with Good Documentation Practices (GDP) and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
- Document Indexing & Categorization: Accurately categorize and index documents according to the DIA TMF Reference Model and the Allucent TMF Index, ensuring easy retrieval and traceability.
- Metadata Verification: Rigorously verify metadata consistency within Veeva Vault, our electronic Trial Master File (eTMF) system.
- Quality Assessment: Assess the quality of submitted documents, identifying and returning non-compliant items for correction to ensure data integrity.
- Trend Identification: Proactively identify trends in documentation issues and escalate concerns to senior team members, contributing to process improvements.
- Team Collaboration: Actively participate in TMF team meetings, sharing knowledge and contributing to a collaborative team environment.
- Mentorship: Provide guidance and mentorship to junior TMF staff, fostering their professional development and ensuring consistent quality.
- Process Enhancement: Support process enhancement initiatives within our Quality Management System (QMS), driving continuous improvement in TMF management practices.
- Client Interaction: Collaborate with clients on TMF-related matters and participate in client evaluations or audits, representing Allucent with professionalism and expertise.
Qualifications and Requirements:
To be considered for the TMF Specialist I position, candidates should possess the following qualifications:
- Education: A Bachelor’s degree in Life Sciences, Healthcare, or Business is required.
- Experience: A minimum of 2 years of experience in TMF document processing within the clinical research industry is essential.
- Clinical Research Knowledge: At least 2 years of experience in clinical research or drug development is necessary to understand the context of clinical trial documentation.
- Regulatory Expertise: Strong knowledge of Good Clinical Practice (GCP), General Data Protection Regulation (GDPR)/Health Insurance Portability and Accountability Act (HIPAA), Case Report Form (CRF), and Clinical Trial Regulation (CTR) guidelines.
- TMF Reference Model: Familiarity with the DIA TMF Reference Model and a comprehensive understanding of clinical trial documentation requirements.
- Communication Skills: Excellent English communication skills, both written and verbal, are critical for effective collaboration and clear communication.
- Attention to Detail: A high level of attention to detail and administrative accuracy is crucial for maintaining the integrity of the TMF.
- Technical Proficiency: Proficiency in Microsoft Word, Excel, and PowerPoint is required. Experience with Veeva Vault is highly desirable.
- Personal Attributes: A proactive, client-focused mindset with the ability to thrive in a fast-paced, dynamic environment. Strong problem-solving skills and the ability to work independently and as part of a team.
Benefits at Allucent:
Allucent is committed to providing its employees with a comprehensive and competitive benefits package that supports their well-being and professional development. Benefits include:
- Competitive Salary & Benefits: A competitive salary commensurate with experience, along with a comprehensive benefits package, including health insurance, paid time off, and retirement plan options.
- Flexible Work Environment: Flexible working hours and a hybrid work setup, promoting work-life balance.
- Professional Development: A training budget and access to professional development platforms to enhance your skills and knowledge.
- Leadership Opportunities: Opportunities for leadership development and mentoring within the company.
- Recognition Programs: Recognition through Spot Bonus and Loyalty Award programs to acknowledge outstanding contributions.
- Internal Growth: Access to internal growth opportunities and the Buddy Program to support your career progression within Allucent.
How to Apply:
If you are a motivated and detail-oriented individual with a passion for clinical research and a desire to contribute to the success of innovative biopharma companies, we encourage you to apply. Please submit your resume and cover letter detailing your qualifications and experience. We look forward to hearing from you!