TMF Specialist

4 weeks ago

Bengaluru Chennai, India Thepharmadaily Full time
Job Description

Key Responsibilities

- Document Processing:
- Process study documents in line with client-specific and study-specific requirements, following ICON SOPs/WPs and applicable regulatory guidelines.
- Collaboration:
- Liaise with study teams and TMF staff to ensure accurate and timely document handling and task completion.
- Project Execution:
- Complete departmental projects within established timelines, maintaining compliance with all relevant regulations.
- File Maintenance:
- Maintain study files in accordance with study/client specifications, ensuring consistency and accuracy.
- Document Management:
- Handle document receipt and processing, including:
- Scanning
- Indexing
- Quality control
- Copying
- Filing
- Archiving
- Reporting:
- Provide status updates and necessary information for client and departmental reports upon request.
- Issue Escalation:
- Notify the Manager regarding:
- Training needs
- Project activities
- Quality concerns
- Timeline risks
- Document Requests:
- Supply copies of study documents to ICON or client personnel as required.
- Audit Support:
- Participate in client and ICON audits and assist with document archiving activities as needed.
- Training:
- Engage in ICON/client-mandated training relevant to your role and responsibilities.
- Other Duties:
- Perform special projects or additional tasks assigned by the Manager.

Requirements

Experience

- 115 years of experience working with TMF (Trial Master File)
- Strong understanding of clinical study documentation and GCP compliance

Skills

- Excellent oral and written communication skills
- Proven ability to collaborate effectively with cross-functional teams, clients, and leadership
- Detail-oriented with a focus on accuracy and regulatory compliance

Education

- Bachelor's degree in Life Sciences (preferred)
- Equivalent experience in clinical documentation may be considered

  • TMF Specialist

    4 weeks ago

    Bengaluru, Karnataka, India Thepharmadaily Full time

    Job Description- Process study documents in line with client and study requirements, adhering to ICON SOPs/WPs and relevant regulations.- Liaise with study teams and other TMF staff to fulfill responsibilities effectively.- Complete departmental projects as assigned, ensuring adherence to timelines and regulations.- Maintain study files per study/client...

  • TMF Specialist

    4 days ago

    Chennai, Tamil Nadu, India ICON plc Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    TMF Specialist - India, Chennai Hybrid: Office-basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAt ICON, it's our people that set us apart. Our...

  • Tmf Specilaist

    23 hours ago

    Chennai, Tamil Nadu, India ICON Full time

    As a TMF Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. - Ensure consistent receipt, analysis, classification, registration and /filing/retrieval of electronic clinical trial essential and non-essential documents and other clinical trial related documents. -...

  • Accounts Payable Specialist

    4 days ago

    Bengaluru, Karnataka, India TMF Group Full time ₹ 5,00,000 - ₹ 10,00,000 per year

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF GroupTMF Group is a leading global provider of...

  • Senior Document Management Specialist

    6 days ago

    Bengaluru, Karnataka, India beBeeDocumentManagement Full time ₹ 1,04,000 - ₹ 1,30,878

    As a Senior Document Management Specialist, you will play a pivotal role in ensuring compliance with our organizational values:Embracing and contributing to our culture of excellence and process improvement is paramount.Beyond Compliance:You will develop and implement Trial Master File (TMF) specifications that align with program strategies and...

  • API Tester Specialist

    4 days ago

    Bengaluru / Bangalore, Amaravati, Andhra Pradesh, Chennai, India beBeeTest Full time ₹ 8,00,000 - ₹ 12,00,000

    API Test EngineerWe are seeking a skilled professional to design and execute API test cases for TMF-compliant REST APIs. The ideal candidate will have hands-on experience in testing TMF APIs, validating application behavior via Dynatrace logs, and implementing functional automation testing using Apache JMeter.Key Responsibilities:Design and execute API test...

  • Technology Architecture Senior Specialist

    14 hours ago

    Bengaluru, Karnataka, India Telstra Full time US$ 1,50,000 - US$ 2,00,000 per year

    Employment TypePermanentClosing Date30 Aug :59pmJob TitleTechnology Architecture Senior SpecialistJob SummaryJob DescriptionRole purpose: As a Senior Technology Architecture Specialist, you thrive on understanding and translating customer needs into fit-for-purpose technology architecture patterns and artefacts that can be employed by solution teams, driving...

  • Healthcare Specialist

    7 days ago

    Bengaluru, Karnataka, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Medical Reviewer RoleThe Medical Reviewer plays a pivotal role in ensuring the highest level of quality and consistency in medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulations.This position requires close collaboration with study team members,...

  • Lead Clinical Data Management Specialist

    18 hours ago

    Bengaluru, Karnataka, India beBeeClinicalDataManagement Full time ₹ 10,00,000 - ₹ 15,00,000

    Clinical Data Management Role:Our team is seeking a skilled Lead Clinical Data Management Specialist to lead data management activities across clinical trials. The ideal candidate will have experience in ensuring high-quality data acquisition, database design, and data integrity.Lead clinical data management activities across assigned clinical...

  • Software Systems Integration Specialist

    4 days ago

    Bengaluru, Karnataka, India beBeeIntegration Full time ₹ 12,00,000 - ₹ 17,00,000

    Job Overview">We are seeking an experienced Integration Specialist to join our team and play a key role in the development and implementation of our OSS integration solutions.">The ideal candidate will have a strong background in IT-Telecommunications industry, with at least 4-8 years of experience in order management systems like OSM 7.3 and...