Planet Pharma · 1 day ago
Clinical Database Builder (EDC) - Medrio
United States
Contract
Remote
Mid, Senior Level
3+ years expPlanet Pharma is a leading Medical Equipment Manufacturer seeking an experienced Clinical Data Management Specialist with expertise in Medrio. The role involves leading clinical data management from study planning to database lock, ensuring high data quality through collaboration with various clinical teams and managing EDC systems.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Brad Phelps
Responsibilities
Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs)
Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements
Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives
Participate in study team meetings
Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol
Lead User Acceptance Testing (UAT) to validate build specifications
Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed
Lead database clean, lock, export, and archiving activities
Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks
Continuously assess and enhance the EDC systems to improve efficiency and data quality
Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan
Coordinates AE/DD reconciliation with PI
Identify and communicate data issues and/or query trends to study team and/or management
Assist with developing metrics on study progress and routinely report out to study team and management
Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures
Contribute to the maintenance of GCA’s data management procedures and work instructions
Responsible for leading or collaborating on process improvement initiatives within department
Meet study timelines with a high degree of quality
Other duties as needed or required
Qualification
Required
3-5 years of overall experience
Minimum of 3 years EDC database programming and Data Monitoring experience
Minimum of 2 years medical device and/or pharmaceutical clinical research experience or similar regulated industry
Bachelor's degree in life sciences, computer science, or related field
Experience with Medrio
Understanding of clinical research regulations
Experience in questionnaire development, database structure, and data management processes
Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams)
Preferred
Certified Clinical Data Manager (CCDM) via SCDM or similar
Knowledge relating to continence care, critical care and/or ostomy
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
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
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase