Join to apply for the Clinical Data Manager role at Katalyst CRO Join to apply for the Clinical Data Manager role at Katalyst CRO Independently identify, prioritize, and lead all CDM activities for assigned study. Represent CDM function at internal/external team calls. Communicate and able to provide CDM expertise for DM related activities. Responsible for ensuring the following activities are set up and reviewed for quality, including but not limited. CDM study file setup and periodic DM reviews to ensure currency of the study file. Ensure proper versioning control in all DM documentation. Data Management Plan review, finalization, modifications. Data transfer specifications review, finalization, modifications. Ongoing manual data reviews and quality reviews of query process. Appropriately communicate data issues and ensure full execution of resolution. Data cleaning. Familiar with medical term coding using MedDRA, WHO Drug dictionaries. Data reconciliation of SAEs between the CRF and safety database. Data reconciliation of third-party vendor data between the CRF and third-party vendor data (e.g. key header reconciliation of lab data to CRF header data). Understanding of internal, external data flows and ensure proper execution of data transfers per the Data Transfer Specifications. EDC access requests management. Ensure ongoing DM study metrics reporting is being communicated at team calls and outstanding items are actioned appropriately. End to end experience in all phases of a clinical study from a DM perspective: startup, maintenance, closeout. Responsibilities Independently identify, prioritize, and lead all CDM activities for assigned study. Represent CDM function at internal/external team calls. Communicate and able to provide CDM expertise for DM related activities. Responsible for ensuring the following activities are set up and reviewed for quality, including but not limited. CDM study file setup and periodic DM reviews to ensure currency of the study file. Ensure proper versioning control in all DM documentation. CRF design, review, finalization, modifications. Database design, review (user acceptance testing/documentation), finalization, modifications. Data Management Plan review, finalization, modifications. Edit check specifications design, review, finalization, modifications. Data transfer specifications review, finalization, modifications. Ongoing manual data reviews and quality reviews of query process. Appropriately communicate data issues and ensure full execution of resolution. Data cleaning. DM listings design, review, finalization, modifications. Familiar with medical term coding using MedDRA, WHO Drug dictionaries. Data reconciliation of SAEs between the CRF and safety database. Data reconciliation of third-party vendor data between the CRF and third-party vendor data (e.g. key header reconciliation of lab data to CRF header data). Understanding of internal, external data flows and ensure proper execution of data transfers per the Data Transfer Specifications. EDC access requests management. Ensure ongoing DM study metrics reporting is being communicated at team calls and outstanding items are actioned appropriately. End to end experience in all phases of a clinical study from a DM perspective: startup, maintenance, closeout. Requirements: Bachelor's degree. 5-7 years of increasing DM experience in Pharmaceutical or Biotech Clinical Data Management. Proficient in computer technology used in an office environment (Microsoft Word, Excel, PowerPoint). Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations. Experience with Science 37 EDC platform is highly preferred, but not limiting. Experience with Medidata RAVE, SAS, and Coding tools. Strong understanding of good clinical data management and documentation practices. Strong attention to version and change control process. Awareness and familiarity of statistical methodologies and outputting (e.g. TLFs). Ability to solve complex problems in all areas of data management. Strong DM project management skills. Effective and professional communication skills, both verbal and written. Ability to work independently in a remote environment and virtual setting. Strong attention to detail. Seniority level Seniority level Mid-Senior level 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 Sign in to set job alerts for “Clinical Data Manager” roles. Sr. Clinical Research Data Manager - 118149 Maryland, United States $71,100.00-$97,800.00 4 days ago University of Maryland Medical System, Registered Nurse (RN), MedSurg/Tele, Staffing Center - Application via WayUp University of Maryland Medical System, Registered Nurse (RN), Comprehensive Medical Rehabilitation Unit, Days - Application via WayUp Registered Nurse (RN), Labor and Delivery, Staffing Center University of Maryland Medical System, Registered Nurse (RN), Stroke Unit, Days - Application via WayUp Registered Nurse (RN), Comprehensive Medical Rehabilitation Unit, Nights Ultrasound Technologist - Registered - AAD Ultrasound Technologist - Registered - AAD Ultrasound Technologist - Registered - AAD Registered Nurse (RN), Comprehensive Medical Rehabilitation Unit, Nights Registered Nurse (RN) MedSurg/Tele, PRN, Nights, Staffing Center Registered Nurse (RN), Stroke Unit, Days Registered Nurse (RN), Traumatic Brain Injury Unit, 10K Sign On Bonus, Nights Registered Nurse (RN), Spinal Cord Unit , Nights, $10K Sign-On Bonus Senior Quality & Performance Improvement Analyst Sr. Research Program Coordinator - 118253 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
Job Description Job Description Job Opportunity: Full-Time Retail Sales Associate at a Womens Designer Consignment Boutique Are you passionate about fashion and providing exceptional customer service? Do you have an eye for designer brands and a love for all...
...Job Description Job Description Description: Position Title: Primary Care Physician Reports to: Operations Manager Location: Caldwell, ID Employment Status: Full-Time FLSA Status: Exempt Position Summary: Aldevra is seeking highly qualified Primary...
...Position Title: Technical Writer - Policy & Standards Writer Location: Phoenix, AZ - Remote Duration: 6+ Months Job Description: Responsibilities Develop and maintain policies, standards, and response plans for a range of incident types. Partner with...
...Job Description Vista Staffing is seeking a Nurse Practitioner Neurosurgery for a locum tenens job in Madison, Wisconsin. Job Description & Requirements ~ Specialty: Neurosurgery ~ Discipline: Nurse Practitioner ~ Duration: 13 weeks ~40 hours per week...
...demonstrated ability to think tactfully and influence key business leaders. ~ Professional (LPP), Certified Forensic Investigator (CFI), preferred ~ Skills in business financials (e.g., payroll, profit and loss) and driving shortage reduction ~ Skills in driving business...