Planet Pharma · 13 hours ago
Clinical Data Manager
Planet Pharma is seeking a Clinical Data Manager to provide Data Management support for assigned programs. The role involves collaborating with the CDM Lead, monitoring vendor quality, maintaining timelines, and supporting data management activities across teams.
Responsibilities
Work with Clinical Data Management (CDM) Lead to support operational activities for one or more programs
Monitoring data management vendor quality of work through key performance metrics
Maintain program level DM deliverable timelines in accordance with program development strategy. Escalates timeline issues, as needed
Supports data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks
Drafts eCRF design and edit check specifications; supports cross-functional review
Perform cross-functional sponsor EDC user acceptance testing
Interacts with external data vendors, develops data transfer agreements
Supports development and implementation of key data and metrics reports/listings
Drafts and performs review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans and DB Go Live and Lock documentation
Qualification
Required
Minimum 8+ years of clinical trial data management experience in the pharma/biotech industry
Extensive technical experience using electronic data capture systems
Demonstrated experience with Medidata Rave
In-depth knowledge of DM industry standards, best practices and CDISC/CDASH implementation
Ability to adapt and manage competing and rapidly changing priorities
Effective in proactively identifying issues and supporting teams in the development of creative solutions and compliant decisions
Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment
Ability to work independently and dependably meet project timelines
Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook)
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase