Tmf Associate Ii

5 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 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 fulfill 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 Labcorp 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 & Client Audit as per study requirements.
- Collaborates with all members of BP&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 other related duties as assigned.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

Privacy Statement

.

  • Tmf Reviewer Ii

    2 weeks 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...

  • Tmf Reviewer Ii

    2 weeks 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...

  • Ssua- I

    2 weeks 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

    2 weeks 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,...

  • Centralized Study Associate Ii

    2 weeks 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...

  • Regulatory Affairs Associate Ii

    1 day ago

    Bengaluru, India Whatjobs IN C2 Full time

    Role: Regulatory Affairs Associate II Work location: Mumbai & Bangalore Summary: The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products....

  • Audit Associate II

    2 weeks ago

    Bengaluru, India Elliott Davis Full time

    Our Mission, Vision, and ValuesMission: To provide exceptional service for our people, our customers, and our communities.Vision: To elevate all experiences by caring more.Values: Do the right thing, Service to others, Mutual Respect, Always Getting Better, QualityPosition OverviewThe Audit Associate II provides valuable and quality assistance in the audit...

  • Audit Associate II

    4 weeks ago

    Bengaluru, India Elliott Davis Full time

    Our Mission, Vision, and Values Mission: To provide exceptional service for our people, our customers, and our communities. Vision: To elevate all experiences by caring more. Values: Do the right thing, Service to others, Mutual Respect, Always Getting Better, Quality Position Overview The Audit Associate II provides valuable and quality assistance in...

  • Audit Associate II

    3 weeks ago

    Bengaluru, India Elliott Davis Full time

    Our Mission, Vision, and Values Mission: To provide exceptional service for our people, our customers, and our communities. Vision : To elevate all experiences by caring more. Values : Do the right thing, Service to others, Mutual Respect, Always Getting Better, Quality Position Overview The Audit Associate II provides valuable and quality assistance in...

  • Audit Associate II

    3 weeks ago

    Bengaluru, India Elliott Davis Full time

    Our Mission, Vision, and Values Mission: To provide exceptional service for our people, our customers, and our communities. Vision : To elevate all experiences by caring more. Values : Do the right thing, Service to others, Mutual Respect, Always Getting Better, Quality Position Overview The Audit Associate II provides valuable and quality assistance in the...