Cytokinetics
Director, Clinical Data Management Systems and Standards
Cytokinetics, South San Francisco, California, us, 94083
We view our employees as the unequivocal ingredients to success. Every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While the expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health and lives of people with cardiovascular and neuromuscular diseases of impaired muscle function.
As a senior leader in the CDM group and subject matter expert for CDM, the individual in this position will oversee data management activities associated with the development and management of CDM systems and their associated processes including but not limited to EDC, Clinical Data Management Programming, system integrations (e.g. drug safety, IRT, CTMS) as well as overall CDM operations. The duties of this role include CDM oversight including serving as the business owner for Cytokinetics EDC systems and related technology, creation/maintenance of related standards and processes (e.g. Global Library, System Configuration, User Administration), staffing and line management, process improvement, CDM system process development and implementation, and participation in cross-functional initiatives. The responsibilities of this position also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables, creating, updating and maintaining SOPs to ensure the validity of clinical trial databases and external data sources, and being familiar with the implementation of data standards and Good Clinical Practice (GCP) as they apply to CDM. The individual will also provide leadership within CDM by leading organizational change, driving engagement, and creating a climate where staff are motivated to do their best.
This position is a chance to have an impact on the future of Cytokinetics and help us continue to grow! You will pair closely with biometrics, QA, CQA, Clinical Research, Clinical Operations, and Drug Safety to ensure compliance with policies, procedures, and overall clinical study and organizational objectives.
Responsibilities
Serve as the inter-department subject matter expert for EDC platforms (e.g. Medidata) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
Develop and ensure compliance from a CDM / EDC and data programming perspective including the development of SOPs and standardization of operational and technical methodologies
Oversee CDM and data visualization programming functions. Develop the infrastructure, people, standards, and processes to build out this capability within the Cytokinetics CDM department
Ensure the continued development, review and maintenance of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
Provide strategic, organizational, and operational management and guidance to the personnel and teams within the system and standards team, as required
Provide technical and functional oversight of the day-to-day use of CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, and quality control procedures, timelines, and documentation
Lead the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools, eSAE, data lake/warehouse Clinical Data Repository solutions, and AI/machine learning
Develop and maintain the infrastructure, organization, and processes to manage and oversee EDC and other systems programming and development timelines including metrics to track the quality and efficiency of build and development timelines.
Assist with the selection and management of data management vendors; identify potential risks and resolving issues with systems vendors and CROs; oversee vendor management plans and reviewing quality metrics; provides guidance and monitors the progress of DM activities with CROs or other vendors
Contribute to identifying, locating, evaluating, and validating CDM documents, databases, and integrations required for report generation or regulatory submission
Assist with the coordination of non-routine projects as applicable in support of Development Operations initiatives
Assist with leading clinical study programs as required to support company goals and objectives
Collaborate with cross functional peers to facilitate and optimize the product development and registration process
Qualifications
Bachelor’s degree in life sciences (e.g. biology), data science, computer science, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
At least 15 years of relevant data management experience and at least 5 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
Prior experience managing EDC systems (Medidata Rave preferred) trial infrastructure setup & deployment as well as leading CDM process development and improvement
Prior management experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IWRS/RTSM, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems
Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry. Competence in data programming (e.g. SAS, BI / analytics tools, EDC Programming) required
Demonstrated leadership quality and superior organizational and interpersonal skills. Excellent written and verbal communication skills
Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
#J-18808-Ljbffr
As a senior leader in the CDM group and subject matter expert for CDM, the individual in this position will oversee data management activities associated with the development and management of CDM systems and their associated processes including but not limited to EDC, Clinical Data Management Programming, system integrations (e.g. drug safety, IRT, CTMS) as well as overall CDM operations. The duties of this role include CDM oversight including serving as the business owner for Cytokinetics EDC systems and related technology, creation/maintenance of related standards and processes (e.g. Global Library, System Configuration, User Administration), staffing and line management, process improvement, CDM system process development and implementation, and participation in cross-functional initiatives. The responsibilities of this position also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables, creating, updating and maintaining SOPs to ensure the validity of clinical trial databases and external data sources, and being familiar with the implementation of data standards and Good Clinical Practice (GCP) as they apply to CDM. The individual will also provide leadership within CDM by leading organizational change, driving engagement, and creating a climate where staff are motivated to do their best.
This position is a chance to have an impact on the future of Cytokinetics and help us continue to grow! You will pair closely with biometrics, QA, CQA, Clinical Research, Clinical Operations, and Drug Safety to ensure compliance with policies, procedures, and overall clinical study and organizational objectives.
Responsibilities
Serve as the inter-department subject matter expert for EDC platforms (e.g. Medidata) including management of the environment as well as the standards library to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
Develop and ensure compliance from a CDM / EDC and data programming perspective including the development of SOPs and standardization of operational and technical methodologies
Oversee CDM and data visualization programming functions. Develop the infrastructure, people, standards, and processes to build out this capability within the Cytokinetics CDM department
Ensure the continued development, review and maintenance of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards
Provide strategic, organizational, and operational management and guidance to the personnel and teams within the system and standards team, as required
Provide technical and functional oversight of the day-to-day use of CDM systems and related processes, as needed, including EDC build standards, clinical data collection, processing, system integrations, and quality control procedures, timelines, and documentation
Lead the evaluation and selection of future CDM systems infrastructure and solutions including clinical programming and data visualization tools, eSAE, data lake/warehouse Clinical Data Repository solutions, and AI/machine learning
Develop and maintain the infrastructure, organization, and processes to manage and oversee EDC and other systems programming and development timelines including metrics to track the quality and efficiency of build and development timelines.
Assist with the selection and management of data management vendors; identify potential risks and resolving issues with systems vendors and CROs; oversee vendor management plans and reviewing quality metrics; provides guidance and monitors the progress of DM activities with CROs or other vendors
Contribute to identifying, locating, evaluating, and validating CDM documents, databases, and integrations required for report generation or regulatory submission
Assist with the coordination of non-routine projects as applicable in support of Development Operations initiatives
Assist with leading clinical study programs as required to support company goals and objectives
Collaborate with cross functional peers to facilitate and optimize the product development and registration process
Qualifications
Bachelor’s degree in life sciences (e.g. biology), data science, computer science, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
At least 15 years of relevant data management experience and at least 5 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
Prior experience managing EDC systems (Medidata Rave preferred) trial infrastructure setup & deployment as well as leading CDM process development and improvement
Prior management experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IWRS/RTSM, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems
Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry. Competence in data programming (e.g. SAS, BI / analytics tools, EDC Programming) required
Demonstrated leadership quality and superior organizational and interpersonal skills. Excellent written and verbal communication skills
Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
#J-18808-Ljbffr