Fotso Sighom Loveline

• Manage end-to-end TMF activities for assigned studies, from setup and planning through ongoing maintenance, inspection readiness, transfer, and final archival.
• Develop study-specific TMF plans, indexes, and comprehensive Expected Document Listings, ensuring consistent structure and high-quality documentation.
• Implement and refine standardized TMF processes, tools, and governance across global study teams, driving operational efficiency and compliance.
• Serve as the primary TMF liaison for Study Execution Teams, providing training, guidance, and support to ensure effective TMF usage and adherence to requirements.
• Lead TMF inspection readiness activities, conduct completeness and quality reviews, manage Quality Issues, and ensure timely corrective actions.
• Prepare and present TMF metrics, proactively identifying risks and collaborating with study teams to resolve challenges.
• Build strong collaborations with internal functions, CROs, and external partners to maintain aligned and compliant TMF operations.
• Oversee TMF archival, transfers, QC checks, and long-term storage, ensuring compliance with ICH-GCP, FDA CFR, SOPs, and global quality standards.
• Act as vendor liaison for standardized document filing, monitoring performance and ensuring adherence to TMF requirements.
• Partner with CQA and Clinical Quality Compliance teams to maintain ongoing audit and inspection readiness across studies.
• Manage paper TMF archives across multiple sites, develop work instructions for paper TMF management in Marburg, and support consolidations and transfers during site closures.
• Coordinate with Rhenus Paper File Management on escalations, invoicing, and cross-functional tasks to ensure compliant handling of paper records. Experience with sponsor/CRO collaboration, Clinical Documentation & TMF Expertise and +12 skills
• Manage end-to-end TMF activities for assigned studies, from setup and planning through ongoing maintenance, inspection readiness, transfer, and final archival.

• Maintained and updated the TMF in compliance with study timelines and regulatory requirements throughout the clinical trial lifecycle.
• Supported trial activation and closeout processes by coordinating the collection, review, and filing of essential documentation.
• Collaborated closely with cross-functional teams to ensure timely, accurate, and complete TMF documentation.
• Performed regular quality control checks on documents submitted to the electronic TMF (eTMF) to identify and resolve discrepancies promptly.
• Assisted study teams with archiving and electronic filing of study-related documents, ensuring proper organization and ease of retrieval.
• Maintained and updated the TMF in compliance with study timelines and regulatory requirements throughout the clinical trial lifecycle.

• Created, maintained, and provided management and/or tracking reports as assigned.
• Coordinated daily tasks and assignments within the team, ensuring deadlines were met.
• Initiated meeting setups, including scheduling rooms and teleconference information, preparing and distributing meeting materials, writing agendas, taking and finalizing meeting minutes, and issuing these minutes to the team or sponsor.
• Prepared and analyzed information, reports, spreadsheets, manuals, correspondence, and other required documentation.
• Supported the departmental team with project planning, tracking, and management by assisting with action item setup, planning project activities, setting up tracking systems, communication plans, and creating/updating project documentation.
• Produced accurate and professional correspondence for internal and external use.
• Worked directly with the department manager to ensure staff needs were met
• Created, maintained, and provided management and/or tracking reports as assigned.
• Coordinated daily tasks and assignments within the team, ensuring deadlines were met.

• Assisted and supported the study team in the study phases I to IV, which included but was not limited to setting up and maintaining project files and project reporting.
• Translated study documentation from German to English.
• Generated and maintained study-specific tracking spreadsheets and inventory worksheets.
• Created investigator site files, ensuring sites had all relevant documentation and medication.
• Shipped supplies and documents in a timely manner to clients, investigator sites, and IRBs.
• Set up and maintained Trial Master Files, which included but was not limited to source data verification and quality control.
• Assisted in assembling materials and binders for investigators' meetings, where detailed and accurate meeting minutes were taken and distributed to the team.
• Assisted and supported the study team in the study phases I to IV, which included but was not limited to setting up and maintaining project files and project reporting.
• Translated study documentation from German to English.
• Generated and maintained study-specific tracking spreadsheets and inventory worksheets.
• Created investigator site files, ensuring sites had all relevant documentation and medication.
• Shipped supplies and documents in a timely manner to clients, investigator sites, and IRBs.
• Set up and maintained Trial Master Files, which included but was not limited to source data verification and quality control.

• Maintained and managed the Trial Master Files (ISF).
• Maintained source documents and regulatory documentation of clinical trials.
• Resolved queries.
• Archived study-related documents.
• Collaborated in study project management, reporting, and documentation of SAE.
• Managed logistic activities, including distribution and tracking of study materials

• Evaluated §23b MPG studies (Medical Devices).
• Assessed medical devices for accuracy and safety.
• Assisted CRA Coordinators in writing clinical evaluation reports and scientific publications in German and English.
• Created investigator site files and SOPs.

• Literature review
• Fieldwork and networking
• Poster design and presentation

• Analysed different pharmaceutic using ELISA
• Performed test with biochemical reactions to Identify enteropathogenic bacteria