Planet Pharma ยท 1 day ago
Clinical Device Management Associate Analyst
Irvine, CA
Full-time
Onsite
Entry Level
$30/hr - $37/hr
1+ years expPlanet Pharma is looking for a Clinical Device Management Associate Analyst to support device processes associated with clinical trials. The role involves ensuring compliance with regulations, managing device inventory, and collaborating with stakeholders to track trial supplies and maintain accurate documentation.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Patrick Sazama
Responsibilities
Support device processes associated with clinical trials
Ensure compliance with regulations and manage the lifecycle of device inventory and accountability to support clinical trials
Partner with stakeholders to manage inventory and device accountability for sites
Ensure clinical sites are sufficiently set up and stocked with trial supplies and track their lifecycle in related system/tool under general supervision
Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
Retrieve, review, and ensure GDP accuracy and completeness of clinical study documents and performing quality checks with increased complexity
Regularly communicate with site and field team to resolve basic queries
Investigate and analyze discrepancies between site and JDE data on device accountability in collaboration with stakeholders (e.g., Finance, Customer Service, Clinical IT)
Provide training on device accountability process within electronic database (e.g., Salesforce) for cross functional team members (e.g., clinical specialist and field monitors)
Identify, develop, recommend, and implement basic process development and improvement solutions to trial workflow timelines (e.g., device accountability data)
Partner with Quality to resolve device related issues
Compile and analyze data to support regulatory submissions for the regulatory bodies (e.g., FDA)
Qualification
Required
Completed Bachelor's Degree in related field with minimum 1 year of previous related Clinical Trial Support or Clinical operations experience
Experience with an ERP software (i.e., JDE), Salesforce and CTMS (Clinical Trial Management System)
Good computer skills in usage of MS Office Suite including Excel, JDE, electronic database (e.g., Salesforce)
Ability to work 5 days on-site
Good knowledge of regulatory requirements and documents (e.g., Code of Federal Regulations, Good Clinical Practices, Good Documentation Practices)
Good understanding and knowledge of clinical trial master files (TMFs)
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