Associate Director eTMF - KlinEra Global Services Inc

Qualifications

• Bachelor’s degree in life sciences/ related field, post graduate strongly preferred.
• Minimum of 7+ years of experience in clinical data management/ eTMF management, with at least 4+ years in a leadership or senior role.
• General knowledge of clinical trials and basic principles of overall trial planning and execution; experience in handling clinical trial-related documents.
• Excellent knowledge of ICH-GCP guidelines and FDA/EMA/PMDA regulations.
• TMF experience with a focus on TMF management function.
• Direct experience with Veeva Clinical Vault (eTMF/CTMS).
• Excellent working knowledge of the TMF Reference Model, ALCOA+ standard, Expected Document Lists (EDLs) and Milestones, ICH-GCP guidelines, and Good Documentation Practices.
• Proven ability to drive process improvements and manage multiple projects simultaneously.
• Proficiency in managing a team and providing leadership to drive performance.
• Highly effective organizational skills and possesses high standards of great attention to detail.
• Strong communication skills – verbal and written.
• Ability to manage a high volume of tasks within a given timeline.

Responsibilities 

• Oversee day-to-day management of TMF operations and FSP services.
• Ensure quality management of studies by analyzing and reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues, e.g., CAPAs.
• Partner with study teams to conduct quality checks of the TMF for inspection readiness and audit/inspection preparation, with the goal of compliance with regulations, ICH guidelines, and internal procedural requirements.
• Develop and streamline TMF processes and workflows to enhance efficiency and data quality.
• Execute TMF archival activities.
• Implement standardized TMF practices across clinical trial teams to ensure consistency and adherence to best practices.
• Author and maintain TMF procedural documents such as SOPs, Work Instructions, the TMF Index, and other guidance documents. 
• Conduct routine and ad hoc TMF training.
• Provide guidance, training, and mentorship to TMF team members on TMF regulations, processes, and systems.
• Collaborate closely with Clinical Operations, Regulatory Affairs, Data Management, and other departments to ensure alignment and integration of TMF activities.
• Partner with Clinical Quality Assurance in support of risk mitigation strategies, corrective and preventative actions, and issue resolution, along with proactively communicating changes, updates, and issues to all TMF stakeholders.
• Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and TMF system changes to ensure continued improvements and compliance.
• Perform periodic TMF Quality, Timeliness, and Completeness Reviews to maintain an inspection readiness throughout the clinical trial.
• Facilitate the planning and execution of periodic TMF content reviews by accountable study TMF Content Reviewers.
• Provide feedback, support, and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.
• Lead the TMF team, fostering a culture of excellence, accountability, and continuous improvement.