For a biotech client of ours in the region of Antwerp we are looking for a TMF owner. Do you have extensive TMF experience and recognize yourself in the description below ? Then pick up the phone and give us a call !
Job Description
TMF Subject Matter Expert and advisor for the Clinical Study Teams on (e)TMF set-up, management, close-out and quality control to ensure a complete and accurate TMF. Implement consistency across clinical studies and programs. Provide crucial TMF quality support to and establish a proactive quality-focused partner-relationship with the Clinical Study Teams.
Responsibilities
- Act as TMF subject matter expert and super user for GLPG eTMF tool; manage & maintain training for new comers and refresher training to existing users. Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes
- Communicate to the Clinical Study Assistants and TMF specialists on all aspects of the TMF projects.
- Provide input on the revision of TMF related Work Instructions, Guidelines, Forms (e.g. TMF plan, oversight/QC tracking tools) and SOP. Provide advice on the implementation of GLPG TMF procedures and standards
- Support Clinical Study Assistants (CSA) and Leaders (CSL) in the set-up and maintenance of an eTMF for assigned studies; oversee Clinical Study start-up, conduct and close-out including impact assessment of potential changes
- Provide guidance, clarification and strategy for regulatory requirements and compliance
- Guide the study teams in the creation and maintenance of the study specific TMF plan
- Ensure – in cooperation with ITS – smooth transfer of vendor TMF components following Data import processes for electronic components.
- Set-up agreements with vendors (on governance level) on TMF processes and transfers
- Support multifunctional Clinical Study Team(s) and/or related stakeholders in resolving issues identified during TMF management, including during electronic document uploads into internal systems (eTMF/eDMS)
- Coordinate TMF related Inspection Readiness initiatives.
- Provide input and advice to audit report responses
- Provide reports and metrics on completeness and quality of TMF documentation and content to Head Clinical Operations on regular basis; monitor timelines and document quality standards; take the appropriate relevant actions to address gaps, issues and risks; Analysis of error trends to promote continuous improvement, providing input to CSAs/ TMF specialist..
- Maintain a global tracking of TMF locations during study and upon archiving, e.g. GLPG TMF, vendor TMFs
- Oversee the archiving activities of TMF components from all relevant stakeholders
- Coordinate inventory activities for off-site storage records (old studies), as appropriate
- Participate in/present at departmental meetings
- Actively initiate and participate in Process Improvement initiatives
Requirements
- Minimum Master in life sciences or equivalent by experience
- Good understanding of drug development as well as a solid experience in clinical study management is highly recommended.
- Experience in TMF management, knowledge of TMF Reference Model, ALCOA+ standard, Good Documentation Practices or relevant working experience in pharmaceutical/scientific environment: i.e. thorough understanding of the processes associated with the conduct of clinical studies and document management operations.
- Exposure to process improvement initiatives and creation of SOPs, guidelines and templates is highly recommended
- Experience working in a matrix managed environment and ability to adapt to corporate culture.
- Excellent knowledge of ICH/GCP E6(R2) guidelines and other applicable regulations.
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
- Have high level Microsoft Office (Excel, PowerPoint, Word, Outlook, Excel) knowledge
- Ability to remain calm/focused in high-stress situations and maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
- Be flexible, pro-active, self-motivated and able to work independently with minimal supervision. Be able to prioritize and seek input where necessary
- Good verbal and written communication skills
- Good leadership and presentation skils