4 Remote Senior Clinical Data Manager (W2 Required) Jobs in Summit, NJ
Remoteworker Us is Hiring a Remote Remote Senior Clinical Data Manager (W2 Required)
Role and Responsibilities:
- Lead the development and refinement of eCRF forms, specifications, and completion guidelines, ensuring alignment with study protocols and regulatory requirements.
- Proactively devise and implement robust edit checks, query logic, and data query resolution strategies to maintain data integrity and quality.
- Take ownership of Serious Adverse Event (SAE) reconciliation between clinical and pharmacovigilance databases, ensuring meticulous consistency and accuracy.
- Design and execute clinical data standards, data management plans, data transfer agreements, and data flow processes, adhering to industry best practices and regulatory standards.
- Manage vendor relationships and promptly resolve data discrepancies to guarantee the availability of complete datasets for analysis.
- Lead data migration processes and oversee database closeout activities, ensuring seamless transitions and compliance with regulatory guidelines.
- Act as a key representative of Data Management in cross-functional meetings, fostering effective collaboration and alignment on data-centric activities and deliverables.
- Provide continuous support and guidance to project teams, anticipating and resolving data-related challenges to ensure project success.
- Advocate for the standardization of data management practices across teams and studies, promoting efficiency and consistency.
- Respond to ad-hoc data requests from clinical teams, assisting in data cleaning, entry, and exploratory analysis as needed.
- Support data review processes by comparing data against protocols, amendments, and study manuals, ensuring adherence to study requirements.
- Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
- 7 years of Clinical Data Management experience (oncology experience is preferred) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
- Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
- Excellent interpersonal, communication, and leadership skills
- Consistent, detail oriented, communicative, dedicated to do a job well done
- CRO and vendor oversight experience preferred
- Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Company Descriptionwww.techdataservice.com
Job Summary
Full Time
$125k-152k (estimate)
08/27/2024
09/24/2024
The job skills required for Remote Senior Clinical Data Manager (W2 Required) include Data Management, Clinical Data Management, Clinical Research, Data Capture, Leadership, Analysis, etc. Having related job skills and expertise will give you an advantage when applying to be a Remote Senior Clinical Data Manager (W2 Required). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Remote Senior Clinical Data Manager (W2 Required). Select any job title you are interested in and start to search job requirements.
Similar Jobs
Popular Articles
