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Engaged Employer

Fortrea Development India Private Limited

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3.9

based on 700 Reviews

Video summary

27 Fortrea Development India Private Limited Jobs

Senior TMF Lead

Fortrea

3.9

based on 700 Reviews

13-14 years

Bangalore / Bengaluru

1 vacancy

Senior TMF Lead

Fortrea Development India Private Limited

posted 17hr ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Clinical Research Life Sciences GCP Clinical Trials

+ 2 more

Job Description

Manages and supports a portfolio of studies, in close collaboration with the TMF Leads, Study Portfolio Leads, Study Leads, and any other relevant stakeholders, including the Clients, as applicable. Position provides process, control, coordination, and approval of clinical trial documents, and is responsible for ECD, Phase I-IV electronic trial master file (eTMF).

Summary of Responsibilities:

Attends the TMF-specific Kick-off Meeting with TMF Leads, Sponsor and Fortrea project team to establish expectations, requirements and deliverables in line with ICH and to support scope build.
Performs and/or oversees all TMF Lead responsibilities, as required for the studies within the portfolio/s for which they are responsible.
Mentors the Team of TMF Lead with their Queries and Questions.
Manage one or more Portfolio of studies for TMF completeness.
Ensures overall client satisfaction regarding TMF, for all studies.
Assist in the identification of, and participates in business improvement initiatives to drive quality, productivity and continuous improvement of business processes related to TMF.
Connect with the clients to gauge client satisfaction and identify improvements required.
Collaborate with TMF Leads to ensure inspection readiness.
Support all stakeholders in preparation for TMF Audits and Inspections.
Assists with the resolution and CAPA responses to audit reports.
Demonstrates cost awareness, understands the financial impact of their decisions, and displays concern for cost containment and conservation of resources in activities.
Perform Training and Mentoring as required.
All other duties as needed or assigned.

Qualifications (Minimum Required):

bachelors (3-year) Degree with a Life Sciences/Business focus.
Preferred: Masters s (2-year) Degree with a Life Sciences/Business focus.
Equivalent experience within clinical research environment of a minimum of 13-14 years, may be substituted for education requirements.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Minimum 13-14 years experience working in a clinical research environment.
Clear understanding of GCP and ICH guidelines.
Knowledge of Regulatory/Clinical document requirements.
Experience working in clinical electronic systems preferred.
Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat.
Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
Excellent interpersonal skills.

Physical Demands/Work Environment:

Office working conditions.
Travel less than 10% required for Sponsor Kick-off Meetings, Face to Face Client Meetings, when requested.
Travel within home region and/or other Fortrea office locations.

Employment Type: Full Time, Permanent

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