Clinical Data Manager
Boulder, CO · On-site
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC ...
SC
60 Sc Clinical Data Manager Jobs Hiring Near You
Clinical Data Manager
Boulder, CO · On-site
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC ...
Clinical Data Manager
Irvine, CA · On-site
Clinical Data Manager Location: Irvine, CA USA 92618 Duration: 12 months (Strong Possibility of Extension) Employment Type: W2 Contingent Worker SUMMARY OF POSITION: As a key member of the Global ...
Clinical Data Manager
Irvine, CA · On-site
Clinical Data Manager Location: Irvine, CA USA 92618 Duration: 12 months (Strong Possibility of Extension) Employment Type: W2 Contingent Worker SUMMARY OF POSITION: As a key member of the Global ...
Clinical Data Manager
Woodcliff Lake, NJ · On-site
Senior Clinical Data Manager,Oncology Project Data Management level. Perform DM activities for in-house and outsourced trials: protocolreview, CRF development, database set up activities, data ...
Clinical Data Manager
Woodcliff Lake, NJ · On-site
Senior Clinical Data Manager,Oncology Project Data Management level. Perform DM activities for in-house and outsourced trials: protocolreview, CRF development, database set up activities, data ...
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC ...
Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC ...
Lead Clinical Data Manager
Irvine, CA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Irvine, CA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Irvine, CA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Irvine, CA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
clinical data manager
Jersey City, NJ · On-site
Senior Clinical Data Manager, Oncology -Project Data Management level. -Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data ...
clinical data manager
Jersey City, NJ · On-site
Senior Clinical Data Manager, Oncology -Project Data Management level. -Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Durham, NC · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Durham, NC · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC). * Experience with managing Lab Data, such as PK, PD, and Biomarkers. * Detail-oriented; performs quality and accurate ...
Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC). * Experience with managing Lab Data, such as PK, PD, and Biomarkers. * Detail-oriented; performs quality and accurate ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Durham, NC · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Durham, NC · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Cambridge, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Cambridge, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Clinical Data Manager
Philadelphia, PA · On-site
As a Clinical Data Manager, you will play a critical role in the design, implementation, and management of clinical trial databases and data collection systems. Working closely with investigators ...
Clinical Data Manager
Philadelphia, PA · On-site
As a Clinical Data Manager, you will play a critical role in the design, implementation, and management of clinical trial databases and data collection systems. Working closely with investigators ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Lead Clinical Data Manager
Boston, MA · On-site
Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Clinical Data Manager
Pittsburgh, PA · Hybrid
The Clinical Data Manager develops and manages the data spec development during the implementation phase of a new product launch. This role works cross-functionally with internal departments to ...
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Clinical Data Manager
Pittsburgh, PA · Hybrid
The Clinical Data Manager develops and manages the data spec development during the implementation phase of a new product launch. This role works cross-functionally with internal departments to ...
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Full-time
Re-posted 23 days ago
Job description
Responsibilities:
Requirements:
- Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
- Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities
- Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks
- Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
- Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
- Provide program/study level oversight and expertise for CDM activities for multiple studies
- Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
- Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
- Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
- Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
- Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
- Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
- Assist with routine quality audits as applicable
Requirements:
- Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
- 9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
- Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
- Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
- Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
- Working knowledge of the MedDRA and WHODrug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger
- Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web-based portals)
- Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks
- Excellent verbal and written communication skills
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US