Depuis octobre 2013, FeetMe développe des dispositifs médicaux connectés pour améliorer la mobilité. Avec le vieillissement de la population et le développement des maladies chroniques, la perte de mobilité est un enjeu de santé publique majeur.
Leur ambition ? Devenir le premier partenaire mondial dans la détection précoce des troubles de la marche et de l’équilibre et l’amélioration de leur prise en charge.
Comment ? En développant des semelles avec des capteurs de pression et de mouvement et un logiciel embarqué qui analyse la marche et récolte des données en vie réelle.
The Director of Operations & Project Management is responsible for the planning, oversight and management of timelines, processes, and alignment of services delivered to FeetMe customers as well as for key workstreams within Feetme. This role will provide project management support for all functional workstreams, customers and associated vendor/partner within the clinical team as wells as in collaboration with other functions.
The person in this role will establish and maintain timelines for project deliverables and ensure proper, compliant completion of each project in a seamless manner. This person will stay updated on all applicable regulatory guidelines, identify potential risk, keep detailed records on the progress of projects, follow timesheets and support audit ready documentation. TheyS/he will provide project management leadership and expertise to each customer projects workstream and ensure implementation and execution of activities and quality deliverables as defined by Standard Operating Procedures (SOPs) and Processes. Priority focus for this role will include evaluation of department timelines, organization of project deliverables and alignment with cross-functional teams across the company (Logistics, IT, Product, Data Science and data management).
The clinical Operations Director reports to the CMO.
Duties and Responsibilities:
• As key member of the clinical team, clinical team and the Company Leadership to establish and define the operations support required to successfully deliver, track, manage, and align all customer projects workstreams within the clinical and related departments.
• Accountable for the operational alignment of Pharma/CRO- and Investigator Sponsored Trials, delivery for services for pharma sponsors, operational support of FeetMe sponsored Trials, Vendor Contract review / approval, Statement of Work (SOW) execution, Clinical Operations budget oversight.
• Serves as Leadership point for each vendor workstream in collaboration with internal cross-functional partners, where required, and request/disseminate project and workstream updates
• Participates in internal and joint vendor meetings with oversight for organization, planning, support and logistics
• Responsible for establishing meeting dates, calendar holds, department agendas; distribution of required meeting materials; coordination of activities during meetings; and production of post-meeting minutes / summaries
• Implements processes, procedures and systems that enable efficient review, approval, support, and oversight of projects and workstreams within the Clinical team
• Maintains oversight for organization of documents for audits including: contracts, budgets, regulatory documents, medical resources, study materials, database materials and other departmental reports repository
• Serves as project manager as needed (depending on resources available)
• Is in charge of managing the change orders in relationship with customers.
• Tracks progress of all project activities and develop process to maintain oversight for management, monitoring and reporting on timelines, milestones, and variances
• Liaises with Legal Affairs to confirm all Agreements have been reviewed, up-to-date and fully executed (MSA, GDPR, CDAs, MTA, Consulting Agreements) as well as coordinate monthly meetings on pending items
• Actively develops a high performing team. Provides ongoing Coaching and Mentoring.
Experience & Education Needed:
• Experience working effectively across multi-cultural, multi-location teams
• Minimum of Bachelor’s degree with 8 years of project management / operations leadership experience, required
• Experience working with members of Senior Leadership and providing updated, relevant reports, required
• Experience working with digital technologies, required
• Experience with relevant project management software and other workstream tools, required
• Experience in the medical device field or in scientific research, strongly preferred
• Understanding of drug development, registration, and the marketing process, strongly preferred
Knowledge, Skills and Abilities:
• Must have knowledge of the biotechnology industry and clinical operations
• Demonstrated ability to organize multiple projects simultaneously, gain the cooperation of others, work cross-functionally and communicate effectively with a variety of internal / external stakeholders and across senior management
• Requires initiative and the ability to maintain a high level of productivity with minimal supervision
• Organized, multi-tasker, ability to see the big picture and apply to daily functional operations
• Intellectual curiosity, integrity, creativity, analytical ability and high professional standards are a must
• Fluency in English required
• The position is based in Paris and will require travel to study site, clients & partners
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