Join to apply for the Clinical Data Manager role at Katalyst CRO 3 months ago Be among the first 25 applicants Join to apply for the Clinical Data Manager role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. 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. 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. Requirements: 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. Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Clinical Data Manager jobs in Boston, MA . Greater Boston $175,000.00-$230,000.00 2 weeks ago Senior Manager, Clinical Data Management Cambridge, MA $190,000.00-$200,000.00 3 days ago Senior Manager, Clinical Data Management Boston, MA $190,000.00-$200,000.00 3 days ago Manager, Coding & Quality (Surgery and Endoscopy) Boston, MA $105,000.00-$140,000.00 2 weeks ago Senior Manager, Clinical Data Management Cambridge, MA $91,287.00-$136,930.00 4 days ago Associate Director, Clinical Data Management Greater Boston $160,000.00-$200,000.00 2 weeks ago Associate Director, Clinical Data and Technologies Director/Senior Director Clinical Data Management Senior Manager, R&D Quality Assurance (Hybrid) Manager, Quality Control & Analytical Development Associate Director, Clinical Data Management Manager/Sr. Manager, Clinical Document Specialist Bedford, MA $112,000.00-$192,000.00 2 weeks ago Senior Director, Clinical Data Management Cambridge, MA $253,000.00-$267,000.00 1 week ago Senior Director, Clinical Data Management Associate Director, Polycythemia Vera, US Medical Affairs Oncology Boston, MA $168,700.00-$265,100.00 2 days ago Study Physician- Neuroinflammation, Immunology Cell Therapy Boston, MA $241,613.00-$362,420.00 10 hours ago Associate Director, Polycythemia Vera, US Medical Affairs Oncology Administrative Director of Operations, Pathology 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 Katalyst CRO
...re the people who keep the cloud running. We support all AWS data centers and all of the servers, storage, networking, power, and cooling... ...The SBN Operations team is looking for an Infrastructure Ops Technician to join our expanding Central Infra Ops team. Infrastructure...
...good customer relations with new and existing accounts. Evaluate trade relationships, provide courteous and professional customer service in a timely manner. This position may also be responsible for specific accounts and/or sales areas. Travel may be required. Also responsible...
Join to apply for the Clinical Data Management Manager role at Katalyst CRO This position involves collaborating with internal and external teams... ...them to organizational goals.Additional Details Seniority Level: Mid-Senior levelEmployment Type: ContractJob Function:...
...Process Engineer - Semiconductor EquipmentUS-OR-HillsboroJob ID: 33203Type: Full-Time# of Openings: 1Category: EngineeringCUSA OR - Intel Hillsboro ORAbout the Role Are you seeking an opportunity to be on the cutting edge of technology? Join a dedicated team enabling new...
AllTruckJobs is working with Clark Transfer to find a qualified OTR Owner Operator in Oklahoma! Pay Information $3,500 to $5,000 per week... ...under dispatch via company provided transponder ~ Paid cargo/liability insurance ~ Flexible home time Call us for more...