TMF Manager

Cmed is seeking an east coast based TMF Manager for this client dedicated opportunity.

Essential Functions:

• The Lead TMF Manager is the business owner of the Trial Master File (TMF) management (paper or electronic TMF).
• The Lead TMF Manager is a key member of the Study Team and is responsible for reporting eTMF status.
• He/she prepares the TMF plan to define TMF strategy depending on the study (e.g. study managed internally Vs study outsourced, QC plan depending on study type.
• He/she oversees TMF completeness, Independent Quality Control (IQC) activities performed by the TMF Specialists and follows-up on specific actions with the contributors to ensure TMF compliance and completeness at all time.
• He/she is responsible for the eTMF lock.
• He/she provides eTMF training and support to contributors to ensure the TMF plan and best practices are well implemented and followed.
• He/she ensures filing activities are performed by contributors according to quality standards and reinforce inspection readiness.
• When there are internal audits, the Lead TMF Manager is the representative facing the auditors to provide training to use the eTMF and information on TMF management processes.
• He/she is responsible for answering auditors’ questions.
• Ensuring that list of documents expected for each study in the eTMF tool are in accordance with study specificities.
• Organizing the TMF kick-off meeting and setting-up the TMF Plan.
• Ensuring that filing and pre-archiving of clinical trial documents are completed according to internal standards and timelines.
• Ensuring that clinical trials documents are available for internal audits and inspections (sponsor and sites).
• Is the PAI (Pre-Approval Inspection) contact for TMF aspects.
• In case of inspections by Health Authorities, He/she is the representative facing the inspectors to provide information on TMF management processes.
• He/she is responsible for answering inspectors’ questions on TMF management processes.
• Mentors junior members of the department and participates in specific projects related to the area of records management (i.e. IT project, quality project to align with new regulations, inspection readiness.
• Demonstrated ability to work in full autonomy and take initiatives.
• Efficient collaboration with internal and external partners.
• Organizational, excellent interpersonal and communication skills (verbal and written).
• Results driven in terms of timelines and quality; Customer & quality focused.
• Flexibility, diplomacy, efficient in matrix organization and transverse management.
• Is a change management agent.
• Self-motivation, attention to details while overseeing and connecting with cooperating departments; Understands the clinical development process and GCP's.
• Familiarity with application/systems related to record management (eTMF tool).
• Learns quickly when facing new problems.
• Effective written and oral communication in English, and good interpersonal skills.
• Experience with the management of outsourced activities would be appreciated.
• Performs the study set-up in the eTMF tool
• Organizes the TMF kick-off meeting with the appropriate TMF Contributors and creates the TMF plan for each study in order to describe TMF management strategy and operational activities.
• The content of the TMF plan is discussed during the TMF kick-off meeting, reviewed by the appropriate TMF Contributors and finalized by the Lead TMF Manager.
• This TMF plan is updated throughout the study as needed.
• Provides on-going support (operational and technical) to eTMF contributors He/she ensures training of local staff is provided on SOPs and application/systems related to record management.
• Collaborates with all stakeholders of Record Management Department.
• Provides status during Study Team meetings and generates regular TMF/eTMF & IQC Statuses for contributors to ensure TMF completeness and quality.
• He/she identifies systematic issues, propose action plans and ensure follow-up until resolution.
• Identifies and resolves issues / problems which prohibit normal filing activities by using acquired experience and expertise.

Required Education/Experience:

• High school diploma or equivalent and a minimum of 4 years’ experience in pharmaceutical industry or clinical-related discipline, good understanding of the R&D processes and previous exposure to GCPs/ICH is required.
• At least 3 years of experience with TMF management and/or Bachelor degree.
• Clinical Research experience in clinical operations is desirable.
• Knowledge of ICH Guideline pertaining to the essential documents for the conduct of a clinical trial.
• Curiosity, willingness to be proactive and problem-solving mindset.