Kumquat Biosciences Inc.
Sr. Manager/Associate Director/Director of Data Management
Kumquat Biosciences Inc. - San Diego, California, United States, 92154
Work at Kumquat Biosciences Inc.
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Overview
Sr. Manager/Associate Director/Director of Data Management Join to apply for the
Sr. Manager/Associate Director/Director of Data Management
role at
Kumquat Biosciences Inc. Sr. Manager/Associate Director/Director of Data Management Join to apply for the
Sr. Manager/Associate Director/Director of Data Management
role at
Kumquat Biosciences Inc. Description
You could be just the right applicant for this job Read all associated information and make sure to apply.
The Sr. Manager/Associate Director / Director of Clinical Data Management, working closely with the broader clinical cross-functional team, will serve as a key leader responsible for overseeing the data management function within the Biometrics organization. This key role will be responsible for overseeing the strategic direction, management, and execution of clinical data management activities across our clinical trials. Description
The Sr. Manager/Associate Director / Director of Clinical Data Management, working closely with the broader clinical cross-functional team, will serve as a key leader responsible for overseeing the data management function within the Biometrics organization. This key role will be responsible for overseeing the strategic direction, management, and execution of clinical data management activities across our clinical trials.
Key Attributes
The Associate Director / Director of Clinical Data Management is an exceptional hands-on, highly detail-oriented, innovative, and collaborative leader that possesses the ability to work closely with cross functional colleagues to ensure effective, timely, high-quality data support for clinical development deliverables across the company’s portfolio. The ideal candidate will have a proven record of success in clinical data management, strong leadership skills, and a deep understanding of regulatory requirements and industry standards.
Essential Responsibilities
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Statistical Programming, and Regulatory Affairs to ensure data management activities support overall clinical trial objectives. Manage the data management timelines, budgets, and resources to ensure the successful and timely delivery of data. Develop and implement data management strategies that align with project goals and regulatory requirements. Oversee the planning, design, and execution of data management processes, including data collection, cleaning, and analysis. Lead and mentor junior clinical data management team members, fostering a collaborative and high-performance environment. Ensure data management practices comply with FDA, EMEA, and other relevant regulatory requirements and industry standards. Oversee the preparation and submission of data management documentation for regulatory submissions and audits. Ensures all data management work is performed consistent with quality in accordance with Good Clinical Practices (GCP) Identify opportunities for process improvements and implement best practices in clinical data management. Evaluate and leverage modern technologies and tools to enhance data management efficiency and effectiveness. Oversee relationships with external data management vendors and ensure their deliverables meet quality and timeline expectations. Manage contracts and performance metrics for outsourced data management services. Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines. Acts as clinical data management subject matter expert for internal and external stakeholders.
Requirements
Education:
Bachelor’s or Master’s degree in Life Sciences, Data Management, Information Technology, or a related field.
Experience
10+ years of experience in data management within the pharmaceutical, biotechnology, or CRO industry. Proven track record of managing data management activities for clinical trials, including database design, data validation, and data cleaning. Experience in leading and developing a team of data management professionals. Strong understanding of regulatory requirements and guidelines related to clinical data management. Experience in oncology therapeutic area
Skills
Expertise in data management systems (e.g., EDC systems such as Medidata Rave, Oracle Clinical) and data management processes. Excellent communication and presentation skills, with the ability to convey data management concepts to diverse audiences. Strong problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment. Leadership abilities with a focus on team development and performance management. Ability to work in a fast-paced and dynamic environment.
Salary Description: $120k - $230k Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Kumquat Biosciences Inc. by 2x Get notified about new Senior Associate jobs in
San Diego, CA . Senior Associate – Infrastructure Financial Due Diligence (Canada)Senior Associate, AI and Quantitative FinanceSenior Associate, Health & Benefits ConsultantSenior Associate, Health & Benefits ConsultantSenior Research Associate, Immunology (Temp)Senior Dir. of Development, Jacobs Engineering - 132395Senior Business Analyst with AppDynamics, 1000Eyes and Dynatrace experienceSpecial Prosecutions Section - Senior Legal AnalystBusiness Analyst - State, Local & Education (SLED) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Sr. Manager/Associate Director/Director of Data Management
role at
Kumquat Biosciences Inc. Sr. Manager/Associate Director/Director of Data Management Join to apply for the
Sr. Manager/Associate Director/Director of Data Management
role at
Kumquat Biosciences Inc. Description
You could be just the right applicant for this job Read all associated information and make sure to apply.
The Sr. Manager/Associate Director / Director of Clinical Data Management, working closely with the broader clinical cross-functional team, will serve as a key leader responsible for overseeing the data management function within the Biometrics organization. This key role will be responsible for overseeing the strategic direction, management, and execution of clinical data management activities across our clinical trials. Description
The Sr. Manager/Associate Director / Director of Clinical Data Management, working closely with the broader clinical cross-functional team, will serve as a key leader responsible for overseeing the data management function within the Biometrics organization. This key role will be responsible for overseeing the strategic direction, management, and execution of clinical data management activities across our clinical trials.
Key Attributes
The Associate Director / Director of Clinical Data Management is an exceptional hands-on, highly detail-oriented, innovative, and collaborative leader that possesses the ability to work closely with cross functional colleagues to ensure effective, timely, high-quality data support for clinical development deliverables across the company’s portfolio. The ideal candidate will have a proven record of success in clinical data management, strong leadership skills, and a deep understanding of regulatory requirements and industry standards.
Essential Responsibilities
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Statistical Programming, and Regulatory Affairs to ensure data management activities support overall clinical trial objectives. Manage the data management timelines, budgets, and resources to ensure the successful and timely delivery of data. Develop and implement data management strategies that align with project goals and regulatory requirements. Oversee the planning, design, and execution of data management processes, including data collection, cleaning, and analysis. Lead and mentor junior clinical data management team members, fostering a collaborative and high-performance environment. Ensure data management practices comply with FDA, EMEA, and other relevant regulatory requirements and industry standards. Oversee the preparation and submission of data management documentation for regulatory submissions and audits. Ensures all data management work is performed consistent with quality in accordance with Good Clinical Practices (GCP) Identify opportunities for process improvements and implement best practices in clinical data management. Evaluate and leverage modern technologies and tools to enhance data management efficiency and effectiveness. Oversee relationships with external data management vendors and ensure their deliverables meet quality and timeline expectations. Manage contracts and performance metrics for outsourced data management services. Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines. Acts as clinical data management subject matter expert for internal and external stakeholders.
Requirements
Education:
Bachelor’s or Master’s degree in Life Sciences, Data Management, Information Technology, or a related field.
Experience
10+ years of experience in data management within the pharmaceutical, biotechnology, or CRO industry. Proven track record of managing data management activities for clinical trials, including database design, data validation, and data cleaning. Experience in leading and developing a team of data management professionals. Strong understanding of regulatory requirements and guidelines related to clinical data management. Experience in oncology therapeutic area
Skills
Expertise in data management systems (e.g., EDC systems such as Medidata Rave, Oracle Clinical) and data management processes. Excellent communication and presentation skills, with the ability to convey data management concepts to diverse audiences. Strong problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment. Leadership abilities with a focus on team development and performance management. Ability to work in a fast-paced and dynamic environment.
Salary Description: $120k - $230k Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Kumquat Biosciences Inc. by 2x Get notified about new Senior Associate jobs in
San Diego, CA . Senior Associate – Infrastructure Financial Due Diligence (Canada)Senior Associate, AI and Quantitative FinanceSenior Associate, Health & Benefits ConsultantSenior Associate, Health & Benefits ConsultantSenior Research Associate, Immunology (Temp)Senior Dir. of Development, Jacobs Engineering - 132395Senior Business Analyst with AppDynamics, 1000Eyes and Dynatrace experienceSpecial Prosecutions Section - Senior Legal AnalystBusiness Analyst - State, Local & Education (SLED) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr