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Planet Pharma · 7 hours ago

Clinical Device Management Associate Analyst

Irvine, CA

Full-time

Onsite

Entry Level

$25/hr - $35/hr

1+ years exp

Planet Pharma is seeking a Clinical Device Management Associate Analyst to support device processes associated with clinical trials. The role involves ensuring compliance with regulations and managing the lifecycle of device inventory and accountability to support clinical trials.

BiotechnologyHealth CarePharmaceutical

Responsibilities

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)

Other incidental duties

Qualification

Clinical trial managementDevice accountabilityRegulatory complianceERP software (JD Edwards)SalesforceCTMSAnalytical skillsMS Office SuiteConfidential information managementCompeting priorities managementInvestigational device knowledgeRegulatory documents knowledgeClinical trial master filesAttention to detailProblem-solving skillsOrganizational skillsCritical thinkingWritten communicationVerbal communicationInterpersonal skillsTeamworkBuilding relationships

Required

Bachelors Degree in related field with minimum 1 year of previous related clinical trial support or Clinical operations experience

Preferred

Experience with an ERP software (i.e., JD Edwards), Salesforce and CTMS (Clinical Trial Management System)

Possess strict attention to detail

Ability to work 5 days on-site

Strong problem-solving, organizational, analytical and critical thinking skills

Strong written and verbal communication skills

Strong interpersonal relationship skills

Good computer skills in usage of MS Office Suite including Excel, JDE, electronic database (e.g., Salesforce)

Good understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management

Ability to manage confidential information with discretion

Ability to manage competing priorities in a fast-paced environment

Good understanding and knowledge of investigational device accountability

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)

Ability to interact professionally with all organizational levels and site personnel

Must be able to work in a team environment, including immediate supervisor and other team members

Ability to build productive internal/external working relationships

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control