TMF Lead

Job Title : TMF Lead

Summary:

Key Responsibilities & Duties:

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 5%) domestic and/or international.
• *Primary point of contact for the TMF of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• *Lead the setup of the Study in TMF system.
• *Drive completeness and quality of TMF content for all assigned clinical trials until study close out.
• *Oversee documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.
• *Manage TMF activities in accordance with the contracted budget for TMF Operations.
• *Lead the development and implementation of the TMF specifications, such as process and system changes.
• *Develop and foster sponsor relationships through effective TMF management and communication.
• *Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.
• *Effectively monitor and report on progress of the TMF to all stakeholders.
• *Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.
• Apply lessons learned to continuous improvement of documentation management practices across study teams.
• *Provide education, feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• *Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
• *Assess impact of potential changes to TMF specifications prior to implementation; collaborate with PM or equivalent if modifications are necessary.
• *Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
• *Conduct periodic quality review of Study Specific Document Lists (SSDLs) at all levels and liaise with the Functional Line Document Owners to ensure that all findings are addressed and remediated in a timely manner.
• *Guide Study Team in the effective management of TMF when working with external vendors.
• *Enforce ownership and accountability of TMF documents across study teams. Ensure document quality requirements are agreed to and met by the study team, according to Completeness, Timeliness and Quality metrics. Participate in Company/Departmental initiatives, as requested.
• Mentor new employees in specified TMF Lead tasks and duties, if required
• Undertake other reasonably related duties as assigned.

Experience required

• A minimum of 8 years of clinical research industry experience in operations / Clinical records management/ Regulatory/Quality or equivalent position/experience.
• Clinical Operations /Clinical Documentation Management / Clinical Research industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and TMF operations.
• Have a general understanding of TMF documents (content/flow) generated by different departments.
• Possess a thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.

Academic or Trade qualifications:

Benefit Working with ICON:

Process

Interview

Offer