Sanofi Group Lead Coordinator, Trial Master File Manager in Bridgewater, New Jersey
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 Sanofi 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.
More specifically, the Lead TMF Manager is responsible for:
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 Sanofi 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.
Knowledge And Skills:
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.These issues/problems may include, but are not limited to incomplete filing, illegibility and inappropriate form completion.
Informs the TMF Contributors on pre-archiving activities, the timelines to provide their specific TMF documents and to ensure that all electronic documents are available in the eTMF (for electronic studies).
When the eTMF is complete, he/she approves the eTMF lock request form, and organizes a TMF/eTMF closure meeting.
As necessary, the Lead TMF Manager assesses the need for eTMF unlock, and complete the “eTMF unlock request form” including the reason for unlock. He/she completes the “eTMF relock request form” consequently.
Participates to any internal audits. Participates to the activities related to the TMF during the PAI (Pre-Approval Inspection) preparation.During inspections by Health Authorities (sponsor and/or sites), he/she is the key contact from Record Management facing inspectors to answer their questions relating to TM management processes.
He/she liaises with the RM service team for long term archiving. He/she provides final archiving date to Planning Department.
Participates in procedure writing (Department SOP, User Manuals) and reviews specific conventions and rules in relationship with contributors. He/she participates in the design, execution and documentation of testing needed to support life cycle management of new and existing eTMF applications/systems.
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.
Knowledge of Sanofi SOPs.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.