Global Clinical Data Standards, Senior Therapeutic Area Lead - Hybrid
MSD Malaysia, Los Angeles, CA, United States
* Providing operational expertise and guidance through training development, training delivery and mentoring to members of the Global Clinical Data Standards team.* Maintaining the integrity of standards libraries, ensuring processes as defined in SOPs and work instructions are in alignment with our company quality documentation standards.* Maintaining knowledge of new and evolving industry and health authority guidance; assess impact to our Company's current implementation of end-to-end data standards.* Influencing industry strategic direction and clinical data standards development through active participation in industry organizations and forums. Maintain a communication network among industry peers for the purpose of identifying innovative processes and technology and best practices.* Lead/participate in cross-functional data governance reviews and projects.* Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives.
+ Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.* In conjunction with senior leadership, participate in corporate initiatives by providing guidance and direction in evaluating, re-engineering, designing, implementing, benchmarking, and training for new or enhanced processes, procedures, and technology.
Encourage practical applications of new ideas* Provide expertise on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.* Work with leadership to define and implement KPIs and quality metrics reporting to assure high quality standard components.* Lead and represent GCDS on TAST as required to ensure consistency across the various projects and protocols within the therapeutic areas.* Ensure all therapeutic area work complies with the current standards.
Support the teams in their development of new and modified standards and submission to the required governing bodies.* Lead the review of departmental SOPs, reference documents, execution resources and implementation strategies.* Promote teamwork across GCDS by actively communicating and proactively sharing information.* Understanding of clinical data requirements for Analysis & Reporting* Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines* Comprehensive knowledge of the clinical trial process including data management (e.g., data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.* Advanced knowledge in two or more therapeutic areas* Ability to work with clinical teams to assure consistency across all studies in a clinical development program and/or therapeutic area.* Exceptional education/training/facilitation skills
+ Ability to mentor cross functional colleagues in data standards and metadata management practices.* Experience in defining and implementing continuous improvement projects* Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.* Ability to influence and drive decision making* Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems.* Ability to effectively organize and manage multiple assignments with challenging timelines.* Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas* Exceptional demonstrated organizational, problem-solving and negotiating skills- In-depth (advanced) knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).
* Expertise in various forms of data collection (e.g., eCRF, IRT, Central Lab Data)
* Study Data Tabulation Model (SDTM) expertise* Knowledge of clinical data metadata & information management platforms and systems* Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.* Ability to use programming and other applications to generate insights from data.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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+ Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.* In conjunction with senior leadership, participate in corporate initiatives by providing guidance and direction in evaluating, re-engineering, designing, implementing, benchmarking, and training for new or enhanced processes, procedures, and technology.
Encourage practical applications of new ideas* Provide expertise on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.* Work with leadership to define and implement KPIs and quality metrics reporting to assure high quality standard components.* Lead and represent GCDS on TAST as required to ensure consistency across the various projects and protocols within the therapeutic areas.* Ensure all therapeutic area work complies with the current standards.
Support the teams in their development of new and modified standards and submission to the required governing bodies.* Lead the review of departmental SOPs, reference documents, execution resources and implementation strategies.* Promote teamwork across GCDS by actively communicating and proactively sharing information.* Understanding of clinical data requirements for Analysis & Reporting* Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines* Comprehensive knowledge of the clinical trial process including data management (e.g., data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.* Advanced knowledge in two or more therapeutic areas* Ability to work with clinical teams to assure consistency across all studies in a clinical development program and/or therapeutic area.* Exceptional education/training/facilitation skills
+ Ability to mentor cross functional colleagues in data standards and metadata management practices.* Experience in defining and implementing continuous improvement projects* Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.* Ability to influence and drive decision making* Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems.* Ability to effectively organize and manage multiple assignments with challenging timelines.* Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas* Exceptional demonstrated organizational, problem-solving and negotiating skills- In-depth (advanced) knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).
* Expertise in various forms of data collection (e.g., eCRF, IRT, Central Lab Data)
* Study Data Tabulation Model (SDTM) expertise* Knowledge of clinical data metadata & information management platforms and systems* Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.* Ability to use programming and other applications to generate insights from data.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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