Clinical Data Manager Jobs in the United States
Beckman Coulter Diagnostics
Chaska, MN
Execute clinical data management activities throughout study lifecycle, such as supporting site initiation activities, reconciling electronic data transfers, validating data quality, preparing data for statistical review and/or data management audit, performing database lock and freeze activities, coordinating the archiving of study databases and related documents, and performing close out audits. Lead development of the clinical data management documentation for clinical studies using electronic data capture methods, data management plans, CRF designs, data dictionaries, data validations, data specifications, acceptance criteria, and data transfer agreements.
Beckman Coulter Diagnostics
Miami, FL
Execute clinical data management activities throughout study lifecycle, such as supporting site initiation activities, reconciling electronic data transfers, validating data quality, preparing data for statistical review and/or data management audit, performing database lock and freeze activities, coordinating the archiving of study databases and related documents, and performing close out audits. Lead development of the clinical data management documentation for clinical studies using electronic data capture methods, data management plans, CRF designs, data dictionaries, data validations, data specifications, acceptance criteria, and data transfer agreements.
Katalyst Healthcares & Life Sciences
Menlo Park, CA
Responsibilities: Develop requirements for EDC including CRF and system design; performs and organizes all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT). Experience with web-based EDC (IBM Clinical preferred), clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.
IDEAYA Biosciences
South San Francisco, CA
Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelines. Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
Intellia Therapeutics
Cambridge, MA
They provide day to day oversight and project management for CDM activities, including: EDC/ePRO development, implementation, and maintenance; data review and query management; vendor management; and the coordination and execution of data deliverables. Is the CDM functional representative for the trial(s) at cross-functional and external (vendor/CROs) team meetings to ensure excellence in all aspects of clinical trial data acquisition, handling, and analysis.
Daiichi Sankyo
Basking Ridge, NJ
In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Daiichi Sankyo
Basking Ridge, NJ
The Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required for clinical trials. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Daiichi Sankyo
Basking Ridge, NJ
The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data listings, sample reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.
Daiichi Sankyo
Basking Ridge, NJ
Support Daiichi Sankyo internal business departments, data steward, and sourcing partners with the following activities: capacity planning, problem management, impact of application issues and overall application (s) stability and associated delays (incident management), operational support for data exchange, integration and data loads, communication on issues and resolutions to DSI. The individual in this role owns the support of technical design / development, testing / debugging, deployment, and manages the ongoing operational production operations of analytic dashboards, databases, applications, and integrations supporting Commercial and R&D needs, including scalability and maintainability.
Daiichi Sankyo
Basking Ridge, NJ
Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (e.g., Executive Committee).
Daiichi Sankyo
Basking Ridge, NJ
In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Daiichi Sankyo
Basking Ridge, NJ
Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs and vendors. CSM may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and delivery of study team plan and milestones (e.g.
Daiichi Sankyo
Basking Ridge, NJ
The Manager, Clinical Pharmacology is expected to identify, generate and execute study protocols with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug Metabolism to design, develop, implement and monitor execution of strategies as well as short- and long-term experiments to advance clinical development. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Daiichi Sankyo
Basking Ridge, NJ
In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Daiichi Sankyo
Basking Ridge, NJ
Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup. Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL).
Daiichi Sankyo
Basking Ridge, NJ
Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup. Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL).
AbbVie
Charlotte, NC
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeof this posting based on the job grade for this position. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.
AbbVie
North Chicago, IL
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeof this posting based on the job grade for this position. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.