Sanofi Group Digital Clinical Trial Operations Manager, Bridgewater, NJ in Bridgewater, New Jersey
The Digital Clinical Operations Manager will report to the CSO, Trial Operations, Late Phase and Real World Team Leader and will work on new digital technologies like electronic Clinical Outcome Assessment (eCOA), mobile apps, sensors, artificial Intelligence (AI) and other mobile apps, planned to be used within Sanofi clinical trials. He/She will work closely with ITS department and the other stakeholders (Internal & External) as a bridge from the pilot to mature phases of the technologies implementation. He/she will be the primary contact within the Late Phase & Real Word (LP&RW) group for any transversal projects or working groups around the opportunity for the digital world and its capabilities to improve the Clinical Trial process. In this role you will lead and/or coordinate a Study Team which will deliver operational elements/ activities for the conduct of clinical studies involving the use of new technologies such as for instance Medical devices and connected devices. You will collaborate and contribute to the Clinical Digital Program- Innovation Pipeline and participate in the value assessment, prototyping, scrutiny, and prepare the ramp up and escalation of innovation to clinical studies. You will use data analytics to support the strategic decisions that will ultimately drive operational excellence. The Digital Clinical Operations Manager will bring and keep the expertise and knowledge within the LP&RW group in order to facilitate users’ guidance and considerations of the best practices (directly or by animation of corresponding networks), follow and review SLAs (Service Level Agreement), review, Key Performance Indicators and identification of process improvement opportunities, and responsibilities. Set-up and manage services to ensure that customers are retained, satisfied, and their needs are fulfilled.
Responsible for designing and implementing improved process or operational guidelines in collaboration with the different study teams.
Recommends changes to products or services based on customer needs.
Act as the mediator between the Clinical Study Teams on one end with their needs to meet the Clinical Trial’s objectives and the Digital service provider on the other.
Relies on experience and lessons learned to plan and accomplish goals.
Promotes the creation of lessons learned from the different clinical studies as far as the digital implementation is concerned.
Determines customer service requirements in coordination with customers and vendors by forming focus groups; benchmarking best practices; analyzing information, services and technologies.
Achieves customer service objectives by ensuring alignment across customer needs and strategic plans; development and implementation of actions plan; identification of customer service trends; determining system improvements; implementing changes.
Meets customer service financial objectives by providing rough estimate before engagement.
Improves customer service quality results by evaluating and re-designing processes; establishing and communicating service metrics; monitoring and analyzing results; implementing changes.
Maximizes customer operational performance by providing and technical advice; detecting, diagnosing and resolving problems; disseminating advisories, warnings and new techniques;.
Develop, maintain and report key performance indicators within department and with technology and service partners to ensure quality, timelines and productivity goals are met.
Ensure implementation of “best practices” on the domain.
Create or direct development of standard operating procedures and standard work instructions.
Drive activities related to the Request for Proposals.
Lead and deliver improved functionalities & processes via new solutions or updates to existing solutions.
Ensure project compliance with legal, regulatory requirements and with internal recommendations and standards (quality, security, ITS, data privacy, etc.)
Effectively communicate project expectations to all stakeholders and get their commitments
Supports Region heads and Clinical team to leverage the digital solution for operational impact
Supports the clinical team in order to facilitate the adoption of the solution and ensure benefits for sites, in collaboration with the region heads and key users and in accordance with the R&D policies
At least 3 years of experience in the pharmaceutical industry or clinical-related discipline (including at least 2 years of clinical research experience).
1+ year of prior project management and/or supervisory experience in coordinating international clinical trials is strongly required.
Experience on Information Systems management and/or clinical development.
Experience in project management methodology
Experience in Digitalization project management
Ability to synthesize, to solve problems and to manage budgets
Clinical trial/Clinical trial lifecycle experience `is a plus.
Experience in digital working environment (agile, design thinking, , experimentation), ideally with role as Product Owner
Autonomous, team player and solution oriented
Strong organizational, analytical, Decision-making and problem-solving skills
Ability to handle multiple tasks and to prioritize, Strong risk management skills
Ability to work in the global environment
Ability to adapt and be a change agent
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life