Sanofi Group Lead Clinical Trial Operations Manager, Bridgewater, NJ in Bridgewater, New Jersey
The Lead Clinical Trial Operations Manager (Lead CTOM) is responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards.
The Lead CTOM is responsible for the coordination of internal/external resources and third parties/vendors for the flawless execution of the study.
The Lead CTOM is involved in the scientific conduct of the study and acts with a critical thinking and problem solving mindset.
This role is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. You must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders. The Lead CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of Sanofi products.
Provide oversight of a study to ensure progress according to study timelines
Ensure proper documentation availability
Ensure proper collection and validation of data and documentation in a timely manner
Organize and lead study specific meetings
Collect, synthesize and report study information
Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Products (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process
Participate in selection and management of vendors, development/follow-up of the associated budget
Preparation and oversight of study audits/inspections both internal and external
Provide oversight and preparation for FDA pre-approval inspections (PAI)
Participate in the training of new CTOMs on therapeutic area and general responsibilities within their function.
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.
Advanced Degree in scientific discipline Or equivalent RN preferred
Familiarity and direct experience with digital technologies and innovative solutions/tools applied to the clinical trial environment is appreciated.Data analytics expertise, such as interpretation of vast and unsorted data for the purpose of extrapolating trends, identifying opportunities (e.g. identifying geography, demographics and communities to efficiently support patient recruitment) and translating the raw data into informative notions aimed at supporting the specific business.
4 years of experience in pharmaceutical industry or clinical-related discipline (including at least 3 years of clinical research)
At least 2+ years of prior management and/or supervisory experience in coordinating international clinical trials is preferred
Ability to lead the study team and efficiently work with other CTOMs in the same study
Ability to manage and lead international meetings (e.g. Study Teams)
Ability to anticipate, timely escalate issues and to define appropriate action plans
Ability to lead transversal projects
Capability to challenge decisions/status-quo/requests using risk management approach (e.g. unrealistic timelines, unplanned database snapshot)
Ability to work cross-functionally fostering team spirit and team motivation (e.g. study team or transversal project team)
Demonstrate stakeholder management skills (e.g. ability to manage expectations)
Good Project Management expertise
Good organizational skills including attention to detail and multi-tasking skills
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
Ability to coordinate multiple interfaces, both internally and externally.
Ability to work autonomously to efficiently and effectively provide status reports
Capability to routinely perform oversight on data management activities (data review and analysis, both clinical& operational, to propose actions and a remediation plan)
Ability to appropriately delegate responsibilities for outsourced activities
Good written and verbal communication skills
Good negotiation skills
Strong English skills (i.e., ability to exchange fluently including negotiation, lead international meetings, write meeting minutes/ emails/ study documents / internal & external communication)
Alert on purpose, communicate on issues with proposed action plans
Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
Encourage collaboration and communication within and beyond the team
Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
Experience with vendor management for outsourced activities
Ability to effectively interact with scientists and managers within and outside Clinical Sciences Organization (CSO), serving as internal consultant on assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
Demontrated ability to adapt and be flexible to change, managing internal and external challenges & opportunities
Knowledge of industry data management standards and practices
Understanding of data base concepts
Knowledge of international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes and SOPs)
Strong working knowledge of Microsoft Office
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