Biotechnology client is seeking a Sr. Clinical Data Manager . The Senior Clinical Data Manager to lead Clinical Data Management activities for assigned Oncology clinical studies ( Phase I-IV)
6 + years of CDM experience required .
Key Responsibilities
Act as Lead Clinical Data Manager in collaboration with CRO Data Management Lead
Oversee the work of the outsourced CDM vendor for assigned projects.
Review vendor deliverables for quality and timeliness, including oversight of external data transfers and deliverables in support of data review and reconciliation.
Work with other functions to develop timelines, forecast resources required and ensure that deadlines are met.
Participates as an active member of cross functional clinical study teams, program level teams, submission teams and provide expert guidance on CDM, CDISC and data quality.
Plan and oversee development and testing of clinical data systems, including eCRF design, data review / validation specifications and other clinical data systems.
Ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including data acquisition, data transfer, data reconciliation and review, medical coding, data extract and rolling data freeze, data lock and database lock.
Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy.
Required Qualifications
Bachelors or Master's degree, plus 5+ years of experience
Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA / CFR, ICH / GCP)
Senior HR Data Analyst (100% Remote)
Develop and maintain a deep understanding of HR data sources and ensure data quality and integrity. In this role, you will be responsible for analyzing and presenting employee data to improve workforce decisions in innovative ways that drive business performance and growth. Design and enhance Power ...
Sr. Database Analyst - Data Engineer (Florida Remote)
Leads in the creation and maintenance of data dictionaries to improve organizational data integrity and facilitate user access to data. Effective work experience developing full stack data analytics platforms, integrating, and supporting data systems and working with a combination of both relational...
Senior Clinical Data Manager
A company is looking for a Senior Clinical Data Manager (Contractor) to provide clinical data expertise in Clinical Data Management processes. ...
U.S Citizenship Only - Data Integration Engineer - 100% Remote
This role involves setting up and maintaining permanent data pipelines from diverse sources into our data fusion engines, specializing in drone data, satellite imagery, RF emissions, OPIR data, Ad tech, AIS, ADSB, CTV, and full-motion video data. Seeking a skilled Data Integration Engineer to collab...
Licensed Marriage & Family Therapist (LMFT) or Licensed Clinical Social Worker (LCSW)- 100% Remote - PT/FT Contract -California
WellPsyche Medical Group is actively hiring for Licensed Marriage and Family Therapists, Licensed Clinical Social Workers and Licensed Professional Clinical Counselors! We are a physician-run leader in Telepsychiatry, providing quality therapy and psychiatric services for children, adolescents, and ...
Program Manager - Clinical Quality Assurance (Remote)
Ability to obtain ADPII Clearance - Bachelor's degree in related clinical field - Minimum 5+ years of clinical experience - Minimum of 3+ years of experience managing a quality assurance program - Intermediate level of Excel experience Preferred Qualifications - Excelle...
Sales Manager in Training (100% Remote)
This 100% remote position allows you to earn an incredible living while letting you choose the working hours that are convenient for YOU and your family. ...
Clinical Data Manager
Identify, establish, and recommend data mapping and design to standardize and harmonize large clinical datasets (including real world data) from multiple American Heart Association clinical trials, research studies and registries as well as other large external datasets. Minimum of two (2) years of ...
Clinical Nutrition Consulting Remote Business Office Manager
At Clinical Nutrition, we are dedicated to empowering individuals and organizations with expert nutritional advice and solutions. At Clinical Nutrition, we lead with our mission and the highest level of integrity. We are seeking a detail-oriented and proactive Remote Business Office Director to over...
Sr Manager SAP Master Data Management & Data Governance
SAP MDG concepts – Data Modelling, UI Modelling, Process Modelling, Governance Process, Mass Processing, Metadata Management and Data Quality. The role will report to the Data & Integration CoE leader, and is a key position in a global organization, delivering value to the business and extended digi...