Clinical Data Manager
Charlotte, NC · On-site
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 ...
66 Katalyst Clinical Data Manager Jobs Hiring Near You
Clinical Data Manager
Charlotte, NC · On-site
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 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 ...
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 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 ...
Clinical Data Manager
Chicago, IL · On-site
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 ...
Clinical Data Manager
Chicago, IL · On-site
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 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
Omaha, NE · On-site
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and ...
Clinical data manager
Omaha, NE · On-site
We are seeking a highly motivated and detail-oriented Clinical Data Manager to join our dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and ...
Clinical Data Manager
Dallas, TX · On-site
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 ...
Clinical Data Manager
Dallas, TX · On-site
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 ...
Clinical Data Manager
Boston, MA · On-site
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
New
Clinical Data Manager
Boston, MA · On-site
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
New
Clinical Data Manager
Austin, TX · On-site
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock * The CDM ensures that data is accurate ...
Clinical Data Manager
Austin, TX · On-site
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock * The CDM ensures that data is accurate ...
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
New
Provide support and oversight for the CRO Data Management team. * Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. * Review clinical study ...
New
Clinical Data Manager
Mountain View, CA · On-site
Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from ...
Clinical Data Manager
Mountain View, CA · On-site
Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from ...
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
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 ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity ...
The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close * This includes the EDC build and user acceptance ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close * This includes the EDC build and user acceptance ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What makes Katalyst an attractive place to work?
Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Job description
Responsibilities:
- Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
- Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
- Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths.
- Manage data deliverables processes and database locks, with high quality and efficiency.
- Foster collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.)
- DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct.
- Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
- Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
- Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
- Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
- Participate in development of DM specific SOPs.
- Responsible for oversight of CRO data management activities and integrating the various functional group input.
- All other duties as assigned.
- BA or BS and a minimum of 4 years of relevant experience.
- Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
- 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 work.
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.
- Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.
- Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
- Knowledge of MedDRA and WHO Drug coding.
- Project Management skills, ability to manage multiple projects and meet deadlines.
- Strong interpersonal, organizational, and communication skills.
- Prior experience writing specification documents and/or work instructions.
- Previous vendor/CRO management.
- Previous experience with RTSM, eCOA/ePRO systems.
- SAS programming experience.