Tmf Associate Ii

2 days ago

Bengaluru Karnataka, India Fortrea Full time

**Job Overview**:
Manages the document classification under Smart Inbox and ARC review (as applicable) as well as document deletion.

**Summary of Responsibilities**:

- Maintains an understanding of applicable regulatory requirements.
- Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member
- Responsible for document classification under Smart Inbox (when applicable), ARC review, document deletion. TMF Classifiers or Start Up team members as part of the SSU Vault Model typically fulfil this role (TMF Classifier).
- ** Maintains the TMF in a state of audit readiness for quality and compliance by**:

- Visual quality checks of e-documents prior to release to confirm image clarity and readability.
- Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;
- Comply with metrics established for performance.
- Process and track final essential artifacts required throughout all phases of the study in accordance with company SOPs, sponsor SOPs, GCP and ICH guidelines.
- Manages the identification of operational issues and resolutions related to the TMF.
- Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.
- Participates in Internal Audits and Client Audit as per study requirements.
- Collaborates with all members of BP and S.
- Ensures overall client satisfaction for all studies.
- Participates in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes.
- Maintains an understanding of applicable regulatory requirements.
- Attend internal or external study team meetings as required.
- Perform Training and Mentoring as required.
- And all other duties as needed or assigned.

**Qualifications (Minimum Required)**:

- Bachelor’s Degree with a' Life Sciences/Business focus.

**Experience (Minimum Required)**:

- Minimum 1 to 2 years’ experience working in a clinical research environment.
- Clear understanding of GCP and ICH guidelines.
- Knowledge of Regulatory/Clinical document requirements.
- Excellent interpersonal skills.

**Preferred Qualifications Include**:

- Masters’s Degree with a Life Sciences/Business focus.
- Equivalent experience within clinical research environment of a minimum of 1 to 2 years, may be substituted for education requirements.
- Experience working in clinical electronic systems.

**Physical Demands/Work Environment**:

- Minimal (less than 10%) as required for Sponsor Kick-Off Meetings, Face to Face Client Meetings, when requested.

Learn more about our EEO & Accommodations request here.

  • Tmf Reviewer Ii

    4 days ago

    Bengaluru, Karnataka, India Fortrea Full time

    **Job Overview**: Responsible for performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal Fortrea business needs. **Summary of Responsibilities**: - Position provides process, control, coordination, and approval of clinical trial...

  • Tmf Reviewer Ii

    4 days ago

    Bengaluru, India Fortrea Full time

    Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF). - Maintains an understanding of applicable regulatory requirements. - Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance...

  • Ssua- I

    4 days ago

    Bengaluru, Karnataka, India ICON Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Ssua- I

    4 days ago

    Bengaluru, Karnataka, India ICON plc Full time

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • Study Start Up Associate Ii

    2 days ago

    Bengaluru, Karnataka, India Icon plc Full time

    Study Start Up Associate II - India, Bangalore ICON 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 development At ICON, it’s our people that set us apart. Our...

  • Associate Architect

    2 days ago

    Bengaluru, Karnataka, India ProPMO Services Private Limited Full time

    10+ Years of Experience in EMS/NMS/Telecom DomainExperience in architecting Large Size Products, Micro Service Architecture, Database ModelsUnderstanding of OSS / NMS related standards and experience using the same like TMF, SID, MTNM, MTOSI, etc.,Understanding and Experience in Telecom Technologies and Services **Benefits**: - Provident Fund Schedule: -...

  • Centralized Study Associate Ii

    6 days ago

    Bengaluru, India Labcorp Full time

    Position provides process, control, coordination, and approval of clinical trial documents. Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF). - Maintains an understanding of applicable regulatory requirements. - Managing electronic Trial Master Files (eTMF), (Trial, Country and Site artifacts) for clinical studies in accordance...

  • Iis Azure Administrator

    2 days ago

    Bengaluru, Karnataka, India Apex Info Serve Private Limited Full time

    We are looking for a highly skilled Azure Administrator with a specialization in Microsoft Internet Information Services (IIS) to manage and maintain our Azure cloud infrastructure and web server environments for one of our reputed client who is one of fastest growing Cloud solution provider in India, with offices across, India & Singapore. Industry:...

  • Azure Administrator(Iis)

    2 days ago

    Bengaluru, Karnataka, India TridhyaTech Pvt Ltd Full time

    Industry: IT/Cloud Services Location: Bangalore, Karnataka **Job Summary -** **Key Responsibilities-** **Integration and Collaboration -** **Qualifications: - ** - Bachelors degree in Computer Science, Information Technology, or a related field. - Proven experience as an Azure Administrator with a strong focus on IIS administration. - Deep knowledge of...

  • Associate Ii

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Associate II - AP **Category**:Finance**Location**:Bangalore, Karnataka, IN **Department - Accounts Payable, Finance GBS**About the department** Procurement GBS is the offshoring unit of Global Procurement and is part of Finance GBS Bangalore. Purchasing operations - HQ is a team within Procurement GBS that is overall responsible for indirect spend,...