Description
Department: Research Operations
Status: Full-Time, Exempt
Reports to: Senior Director, Research Operations
Industry: Biotechnology
Position Summary
We are seeking highly motivated and enthusiastic individuals with an eye for detail to join our Research Operations team at 54gene.
This role will oversee the Quality Assurance and Quality Control aspects of all Research study implementation, to ensure all processes are conducted and deliverables attained according to established Standard Operating Procedures (SOPs). Project protocols and all applicable regulatory requirements. He/She will also be a hands-on resource in assisting with internal and external audits.
Roles and Responsibilities
Perform extensive quality assurance review of research study design and implementation documents and data across multiple complex studies and report findings to the research management team
Develops and implements plans and tools for monitoring all research study processes, internally and across our network of collaborating institutions/sites, including participant recruitment processes, biospecimen quality assurance, and data collection practices and control techniques
Define Quality Key Performance Indicators (KPIs) at the respective research project (study) level and individual contributor level
Create and maintain an education and training program for sites: Conducts periodic trainings for all site quality staff on established research quality practices, compliance related topics and effective data collection procedures
Conducts periodic internal reviews and assessments to ensure compliance procedures are being followed: Identifies and analyzes issues, bugs, defects, and other problems, particularly when problems recur; recommends and facilitates effective solutions to these issues.
Carries out regular monitoring visits and/or audit visits, to collaborating institutions on investigator sites, as required
Provides metric reports regarding research study quality and compliance issues to the research management team, for process improvements and to ensure best practices are followed
Develops and tracks site monitoring-related Corrective and Preventive Action Plans (CAPAs)
Contributes to the planning, design, execution, and interpretation of process optimization experiments (process development)
Assists in preparation of reports, regulatory submissions, and the drafting of compliance related monitoring Standard Operating Procedures (SOPs)
Ensures that research studies are initiated, documented, and reported in compliance with internal SOPs, ethical guidelines, sponsor guidelines and current applicable regulatory regulations.
Collect, compile, and analyze relevant quality statistical data to obtain information regarding quality performance.
Participates in internal project audits.
Performs other duties as assigned in support of research project quality monitoring initiatives and 54gene’s business priorities and objectives.
Requirements
Education & Certifications:
Bachelor's Degree in Health Sciences field
Five (5) years' supervisory or equivalent experience in Quality Assurance, Regulatory operations, Field Monitoring and Evaluation, and/or Project Management.
Preferred Masters or other advanced degree (e.g., postgraduate qualifications in quality improvement methodologies such as FMEA, Six Sigma or other similar BOK, preferred
Experience in educating, training or equivalent is required.
Knowledge, Skills & Abilities:
Experience in quality management, including quality assurance and control methodologies
Experience in research, medical or complex administrative setting required, particularly the ability to anticipate and solve problems while analysing and navigating complex issues/environments
Training in, and Experience conducting site audits of epidemiological or other clinical/health research studies
Ability to travel on a regular basis for site-specific management responsibilities and relationship management with study investigators
Knowledge of compliance regulations, as it relates to the ethical conduct of research studies
Excellent verbal and written communication skills
Ability to maintain confidentiality of information, demonstrate good decision-making and judgment, and have attention to detail and follow-through skills
Excellent organizational skills and the ability and initiative to prioritize and handle a variety of tasks and assignments simultaneously.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills with the ability to collect, organize, analyse, and disseminate significant amounts of information with attention to detail and accuracy.
Must have the ability to exercise good judgment in ambiguous situations under pressure and have strong coping skills.
Must have the capacity to comprehend complex structures and connections and be willing to adapt within a rapidly changing environment
Strong supervisory, leadership and facilitation skills, to work collaboratively with different types of team members
Proficient with Microsoft Office Suite or related software and adept at queries, report writing and presenting findings.
go to method of application »
Industry: Biotechnology
Department: Diagnostics
Reports To: VP Engineering
Roles and Responsibilities
Leverage on the powers of PHP, Node js, Vue and React to develop scalable systems.
Determine operational feasibility by analyzing business needs, software requirements and proposed solutions.
Lead other team members to develop high quality Software design and architecture.
Collaborate with other internal teams and vendors to build and improve products.
Support and mentor mid level and junior developers by providing advice and guidance.
Document development phases and drive optimization processes.
Research new technologies, advancements and industry trends in order to stay abreast of latest developments and enhance the success of the company.
Determine root cause of complex problems and develop practical, efficient and permanent solutions.
Write properly formatted codebase as well as implement unit testing.
Review and debug code.
Lead code review sessions.
Requirements
Over 5 years of experience building scalable systems using PHP, Node js, Vue and React. Experience using other technologies will be an added advantage.
An in-depth understanding of data structures and algorithms. And how it can be used in building memory efficient systems.
An understanding of Software Architectures and how they can be efficiently applied to ensure the development of resilient systems.
Expert knowledge of Software Development methodologies and how they can be applied to different project dynamics.
Leadership and coaching skills as well as the ability to manage multiple projects and manage collaboration between team members to produce a final product.
Identify, prioritize and execute tasks in the Software Development life cycle.
Automate tasks using appropriate tools.
The desire to work in a fast paced environment.
Experience building and supporting enterprise applications
Excellent communication skills.
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