An emerging national Clinical Research Organization company that focuses on Oncology is looking for two bright and collaborative Clinical Data Managers for fully remote roles, that can be based across all of the United States. The company is in motion to expand and grow their team with a lot of clinical projects coming down the pipeline. This company has a national reach and is patterned with many great organizations. There is also great progression for the role, as the Clinical Data Managers selected, will report directing to the Head of Biometrics.
As a Clinical Data Manager, the person in this role will be responsible for all data management activities from start-up through closeout of study. The CDM will work with the Clinical Project Manager (CPM) and Biostatistician to ensure the accuracy, timeliness and complete collection of clinical study data. They will be responsible for representing data management in meetings and providing status updates and metrics as needed. Excellent communication skills and a desire to be an active team player are a must.
- Contribute to the design of study databases, case report forms (CRFs) and edit checks
- Perform User Acceptance Training (UAT)
- Develop and maintain proper study documentation throughout the lifecycle of a study, to include, but not limited to Data Management Plans, (DMP), eCRF Completion Guidelines, Database Specifications, Edit Check Specifications, and UAT Test Plans
- Create and validate standard, study specific, and ad hoc study reports
- Perform serious adverse event (SAE) reconciliation between EDC and safety database
- Perform coding and review auto-coded terms within EDC using MedDRA and WHODrug dictionaries
- Perform data transfers from EDC to sponsors
Skills and Requirements:
- Minimum 5 years of clinical trial data management experience in the biopharmaceutical industry or at a contract research organization (CRO)
- Knowledge of industry standards, such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines
- Experience with clinical databases such as Medrio, OpenClinica, Oracle
- Strong understanding of clinical trial processes and EDC platforms
- Excellent verbal and written communication and organizational skills