North America Clinical Study Unit - Quality Lead (REMOTE)

Job description

Job Summary:

The role of Quality Lead (QL) is a North American Clinical Study Unit (NA CSU) (country/cluster and or region) based role reporting directly to CSU Management, and indirectly to the CSU Quality Network. This role acts as an extension to a broader network of quality professionals and teams within the Quality & Continuous Improvement department of the Clinical Sciences & Operations (CSO) Platform. 

The NA CSUQL and is responsible for the quality and training program implementation for all NA CSU clinical, monitoring and support staff. 

The NA CSUQL responsible to  coordinate with quality groups and procedures groups and other subject matter experts to develop quality processes and training programs to encompass policies, procedures, guidelines and other relevant materials essential to clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, corporate, global and local SOPs.  The NA CSUQL works cooperatively with the Associate Director, NA CSU Ops, CPL (Clinical Project Leader), as directed, in the quality adherence and training of new and current NA CSU staff and in completing special projects and assignments to further advance the monitoring program. The NA CSUQL is responsible for training materials for all new and revised Sanofi procedures.

The CSUQL is also a key contributor for GCP-related quality topics occurring at the CSU level such as:  

·  Selection & Qualification of local vendors conducting clinical trial related activities
·  Corrective & Preventive Actions (CAPA) post audit / inspection
·  Investigations for serious GCP non-compliance, alleged scientific misconduct
·  GCP (and where applicable other regulatory) inspections
·  Coordination of Local SOP review with subject matter experts
·  Collaboration with partner(s) to deliver CSU-specific training

Knowledge and Skills:

·  Broaden awareness and understanding of processes, tools, additional regulations governing clinical research, so as to be a resource for the NA CSU staff.
·  Participate in Committees/Task Force Teams/Workgroups on an as needed basis, as requested by Management Team, to provide procedural insights and represent NA CSU interests.
·  Provide oversight of CTMS & CSR quality metrics for studies and programs conducted by affiliate and satellite countries to ensure appropriate study classification and completion of critical CTMS data to ensure regulatory reporting obligations are maintained.
·  Participate in continuous improvement initiatives/PAI, CAPA post audits/post quality reviews and inspections.
·  Participate in investigations for serious GCP non-compliance / alleged scientific.
·  Report and follow up on misconduct relevant to their geographic area.
·  Participate in local GCP inspections.
·  Promote appropriate escalation to CQ&CI any relevant GCP and/or regulatory information that would require further action.
·  Transversal interaction when needed (e.g. quality topic(s), continuous improvement, etc.)

Quality Documents:

·  Act as NA CSUQL, responsible for learning and communicating new corporate and local quality document processes and procedure.
·  Create and launch information letters to CSU for QD updates.
·  Ensure the identification, development and implementation of CSU or country/multi country (local) QDs (e.g. when required by global QDs or local regulations), training, processes.
·  At country level: with the respective CQHs of the concerned countries, for topics such
·  as country quality systems managed by the CQH, inspections and GCP audits.
·  At CSU level: Coordinate and work with local QD authors to make sure QD meet NA CSU and/or US CSU expectations for format and content.
·  Within the community of Clinical Study Unit Quality Leads for collaborative work, sharing experiences and good practices.
·  At global level with stakeholders within CQ&CI
·  Assist in the coordination and conduct of NA CSU workshops and meetings, as required.  Leading and supporting special projects in the digitization of clinical operations (i.e.  virtual clinical trials, EHR, real-world protocol optimization, patient recruitment, engagement & retention, wearables, ePROs, data & analytics).
·  Based on WW QD activity, track needs for local QDs and QD due dates/updates.
·  Ensure maintenance of an historical file of the CSU and/or country/multi country (local) QDs
·  Participate in the definition of quality objectives for the NACSU

Training:

·  Promote and oversee maintenance of appropriate qualification of the CSU staff following recommended training plans (CSO and/or CSU or country/multi country (local) QDs such as OQS, QDs and/ WIN)
·  Manage the local training matrix to ensure compliance with training expectations as required by CSO/Local Quality Documents.
·  Scheduling and coordinating subject matter experts and other training partners for all NA CSU required trainings, system support, pre-approval inspections, SOPs adherence and quality.
·  Coordinate NA CSU training program and conduct systematic, consistent SOP and good work practices training for new NA CSU personnel. Conduct formal training for Monitoring Visit Report Guidelines and CRA Roadmaps, as needed, other essential processes related to NA CSU staff roles and responsibilities.
·  Implement improvements and track progress to enhance the NA CSU training program. Provide input for additional clinical monitoring related training.
·  Oversee deployment / implementation of global training program at CSU level and provide input for additional clinical monitoring related training needed.
·  Implement improvements and track progress of training to ensure appropriate maintenance and archiving of training records for all CSU staff
·  Coordinate and enhance (ie, implement improvements), as needed, the personnel training records tracking program to ensure documentation of training, per the NA CSU SOP.
·  Participate as team member for implementation of new e-Learning and tracking tools.
·  Conduct refresher/retraining courses for current NA CSU clinical personnel in accordance with the local NA CSU SOPs.
·  This position requires a great deal of collaboration and diplomacy skills.  Integration of new procedures and learning tools will require flexibility; training for new things will require additional focus “change management” to gain more proactive and effective uptake by trainees.

Education and Experience required:

Bachelors with an advance degree preferred. Minimum of 8-10 years experience in the pharmaceutical industry and a minimum of 2 years experience in training development/delivery and/or quality support in the conduct of clinical trials. Experience in support of oncology, hematology and rare disease trials

Knowledge And Skills Desirable:

As a requirement for their mission the CSUQL should demonstrate:

·  Training/presentation experience
·  Work experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or pre- clinical area (e.g. pharmacology, toxicology), clinical development
·  Advanced and thorough knowledge of FDA regulations and ICH/GCP guidelines (country, region and international when applicable)
·  Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and presentation/training software tools (e.g., PowerPoint, Camtasia)
·  Robust transversal communication skills to ensure appropriate business interaction with the various global, CSO, CSU departments and functions, and other partners (e.g. CQH)
·  Demonstrated coaching and mentoring skills
·  Ability to work effectively with research personnel, maintaining a professional demeanor
·  Self-motivated; Detail oriented; Team player; Flexible
·  Ability to prioritize workload to meet project timelines, while managing multiple training needs across multiple therapeutic areas
·  Excellent organizational and time management skills
·  Experience working in digitization of clinical operations (i.e. virtual clinical trials, EHR, real-world protocol optimization, patient recruitment, engagement & retention, wearables, ePROs, data & analytics
·  Experience in oncology, hematology, rare diseases
·  Thorough knowledge of clinical systems and ongoing technical industry trends as they relate to the clinical development process
·  Project management methodologies

Major Duties and Responsibilities:

·  Coordinate NA CSU training program and conduct systematic, consistent SOP and good work practices training for new NA CSU personnel. Conduct formal training for Monitoring Visit Report Guidelines and, as needed, other essential processes related to NA CSU staff roles and responsibilities.
·  Implement improvements and track progress to enhance the NA CSU training program. Provide input for additional clinical monitoring related training.
·  Coordinate and enhance, as needed, the personnel training records tracking program to ensure documentation of training, per the NA CSU SOP. Participate as team member for implementation of new e-learning and tracking tools. Conduct refresher/retraining courses for current NA CSU clinical personnel in accordance with the local NA CSU SOPs.
·  Act as NA CSU CQPTA , responsible for learning and communicating new corporate processes and procedures.
·  Participate in Committees/Task Force Teams/Workgroups on an as needed basis, as requested by Management Team, to provide procedural insights and represent NA CSU interests.

Quality Documents:

·  Coordinate and work with local QD authors to make sure QD meet NA CSU and/or US CSU expectations for format and content. Create and launch information letters to group for QD updates. Based on WW QD activity, track needs for local QDs and QD due dates/updates. Manage the local training matrix to ensure compliance with training expectations as required by CSO/Local Quality Documents.
·  Broaden awareness and understanding of processes, tools, additional regulations governing clinical research, so as to be a resource for the NA CSU staff.
·  Assist in the coordination and conduct of NA CSU workshops and meetings, as required.  Leading and supporting special projects in the digitization of clinical operations (i.e.  virtual clinical trials, EHR, real-world protocol optimization, patient recruitment, engagement & retention, wearables, ePROs, data & analytics.
·  Scheduling and coordinating subject matter experts and other training partners for all NA CSU required trainings, system support, pre-approval inspections, SOPs adherence and quality.
·  This position requires a great deal of collaboration and diplomacy skills.  Integration of new procedures and learning tools will require flexibility; training for new things will require additional focus “change management” to gain more proactive and effective uptake by trainees.

Major Challenges/Problems:

Awareness, scheduling and coordinating subject matter experts and other training partners for all NACSU required training. Must ensure learning and training needs of NACSU are met.  Requires a great deal of collaboration and diplomacy.  Integration of new procedures and learning tools will require flexibility; training for new processes and expectations will require additional focus “change management” to gain more proactive and effective uptake by trainees.

Promote quality, in accordance with applicable local and worldwide Quality Documents, in all aspects of work in supporting and leading the NACSU.  Collaborating with managers, leadership team members, subject matter experts to secure compliance is challenged by competing priorities, interests and timelines.

Key Internal/External Relationships:

At country level: with the respective CQHs of the concerned countries, for topics such as country quality systems managed by the CQH, inspections and GCP audits.

·  At CSU level: with other stakeholders such as the CSU System Expert, Clinical Study Unit Safety Lead, Medical Advisors, CROMS and IP manager.
·  Within the community of Clinical Study Unit Quality Leader, System Experts, and Records Specialist networks, for collaborative work, sharing experiences and good practices.  
·  At Global level with stakeholders within CQ&CI

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.

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