Company Overview
Sanofi, a diversified global healthcare leader, discovers, develops, and distributes therapeutic solutions to improve the lives of everyone. We work to prevent and treat the diseases that we know of today, as well as those we may face tomorrow. With nearly 100,000 dedicated professionals in more than 100 countries, Sanofi is devoted to advancing healthcare around the world. Sanofi US, with headquarters in Bridgewater, New Jersey, along with our vaccines division, Sanofi Pasteur, employs more than 11,400 professionals throughout the country.
Sanofi US is dedicated to the ideal that each of us can impact results and play a role in improving the health and well-being of people everywhere. Our extensive research and development efforts address key health care challenges in cardiology, oncology, and internal medicine, as well as metabolic diseases, central nervous system disorders and vaccines.
At Sanofi, we work for what really matters: health.
Job Description
Job Summary:
The Standards Coordination Lead is responsible for the management of the Integrated Clinical Data Standards (ICDS). Responsibilities include accountability of the Clinical Standards Core Team, management of IDCS change requests, and prioritization of therapeutic standards development. He/she will establish and provide leadership to cross-functional working groups.
The Standards Coordination Lead is responsible for the management of the Integrated Clinical Data Standards (ICDS). Responsibilities include accountability of the Clinical Standards Core Team, management of IDCS change requests, and prioritization of therapeutic standards development. He/she will establish and provide leadership to cross-functional working groups.
The incumbent defines and ensures the completion of the ICDS clinical services according to service level agreements with the highest quality. Industry standards (CDISC, BRIDG, ICH & HL7) and internal clinical content applied throughout the information lifecycle will be a primary focus.
He/she drives development of clinical standards and processes supporting the evolution of industry standards, harmonization of standard-related activities across internal organizations and implements of new technology in support of Sanofi's standards infrastructure.
Major Duties & Responsibilities:
Simplify the Integrated Clinical Data Standards library for use by the cross-functional platform for conduct and reporting of clinical trials.
He/she drives development of clinical standards and processes supporting the evolution of industry standards, harmonization of standard-related activities across internal organizations and implements of new technology in support of Sanofi's standards infrastructure.
Major Duties & Responsibilities:
Simplify the Integrated Clinical Data Standards library for use by the cross-functional platform for conduct and reporting of clinical trials.
- Manage formal ICDS proposals including the review, impact analysis and response to any change requests
- Escalate risks to the Clinical Standards Core Team
- Maintain the formal proposal database
- Develop and track metrics to continuously monitor the use of standards and improve the standard definitions.
Chair the Clinical Standards Core Team to report standards activities, resolves open issues and foster endorsement of high risk requests.
Define and manage a services model to support the Integrated Clinical Data Standards including cycle of requests, impact analysis and response to user requests for creation or change of ICDS components.
Promote the adoption of Sanofi standards and standards projects including training, system application and continuous improvement.
Define and agree on a Data Standardization Plan and process for regulatory submission and review.
Negotiate standards adoption with Sanofi partners and alliances to integration harmonized standards modeling including the governance of existing standards and the addition of new standards.
Manage a communication plan for standard updates and evolution.
Create and maintain standard operating procedures and guidance documents related to standard module implementation.
Influence the development of external standards by actively participating in conferences and/or working groups linked to the definition of Industry Standards such as CDISC, CFAST, HL7 or other initiatives.
Key Internal/External Relationships:
all groups of Technology and Information Management
Key External Relationships: including but not limited to Trial Operations, Medical Operations, CEP, Q&CI, GPE, PK, Biostatistics, entrepreneurial units (BU/TSU/DPU), R&D IS
Decision Making Authority:
1. Identify non-standard compliance related issues and implement corrective action plan.
2. Identify, define and implement standards development and quality process improvement measures
3. Escalate risks to the Domain Manager or Clinical Standards Core Team as appropriate
Requirements:
Formal Education & Experience Required:
Formal Education & Experience Required:
- Formal degree in a relevant scientific/health-related field
- Minimum of 8-10 years experience in the pharmaceutical industry, with a minimum of 8 years experience in clinical and quality operations-related roles (e.g., direct study management, monitoring, auditing)
- Experience working within a global team/ environment to produce operational reference standards to meet regulatory requirements across regions
Knowledge & Skills: - Strong knowledge and experience of current regulatory requirements impacting clinical operations and clinical data standards.
- Strong knowledge of clinical information systems and information modeling.
- Knowledge Industry standards (CDISC CDASH, CDISC SDTM, CDISC Controlled Terminology, BRIDG, HL7 RIM), practices, regulations and guidelines relevant to international clinical development.
- High degree of personal accountability and commitment
- Ability to independently prioritize assignments and provide timelines for project completion to working group members, monitor process, progress and results.
- Excellent communication and collaboration with project teams, departmental associates, internal and external partners
- Able to independently provide expert level of guidance to associates on questions relating to information standard components and relevant regulations.
- Ability to recognize issues that may require escalation to senior management levels.
- Expertise in meeting management, with strong group facilitation skills to lead effective cross-location and cross-functional meetings, web meetings, and teleconferences through discussions on complex and potentially controversial topics.
- Ability to multi-task, handling a wide range of small, medium, and long-term assignments in parallel and dealing with urgent issues as they arise
- Anticipates problems, issues, and delays; works proactively and takes the initiative for any corrective measures.
- Excellent written and verbal skills
Knowledge & Skills Desirable but Not Essential: - Knowledge of data modeling tools and techniques
- Understanding and experience with relevant terminologies (WHO, MedDRA, SNOMED CT, etc.) and ISO Data Types is desirable.
- Understanding and experience with XML for exchange of metadata (CDISC ODM or HL7 messaging).
See: http://jobview.monster.com/Manager-Metadata-Curation-Job-Bridgewater-NJ-116822023.aspx (monster.com)