TMF Portfolio Lead

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 other related duties as assigned.
• Perform Training and Mentoring as required.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 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.

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.