Clinical Research Associate at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

05 Apr, 26

Salary

0.0

Posted On

05 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Project Management, Regulatory Requirements, GCP Standards, Quality Assurance, Risk Management, Team Leadership, Communication Skills, Interpersonal Skills, Attention to Detail, Data Management, Clinical Trial Design, Mentoring, Training, Analytical Thinking, Continuous Glucose Monitoring

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: This Clinical Operations Supervisor will provide day-to-day direction, leadership, and execution of conducting sponsor-investigator studies. A successful leader in this role will be knowledgeable in each of the areas provided but also demonstrate a flexible and enthusiastic mindset in establishing new and creative approaches to drive the team forward. This role is fundamental in establishing and conducting a specific team, focused on execution of feasibility clinical studies and will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts with maximum value add and drive the team toward those. Where you come in: You lead, assist, and conduct clinical studies from start-up to closure. You assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision. You develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.). You assist management with departmental audits of clinical studies and procedures. You collaborate with project management, individual contributors, and your direct manager to establish and maintain study timelines. You clearly demonstrate understanding of clinical study management and prioritization. You manage all clinical tasks and deliverables to meet clinical timelines. You supervise a team of Clinical Research staff who execute clinical studies. You mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and Dexcom policies and procedures. You design training strategies to ensure compliance and efficiency. You ensure staff are delegated and trained appropriately and documented. You assist with the management of studies by coordinating daily operations including methods, workflow, and implementation of procedures. You establish KPI and benchmark metrics to measure responsible tasks, improve quality in the conduct of studies, and lead continuous improvement initiatives. You partner with Clinical Affairs management and direct reports to develop and execute clinical studies. You write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners. You incorporate understanding of study objectives and key data points when planning for each assigned protocol. You execute and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs. You work with direct reports to execute assigned clinical trials including start-up, subject recruitment and scheduling, collection of regulatory documents, conducting study visits, ensuring timely data entry and query resolution, managing and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports. You are responsible for identifying and escalating safety events. You are responsible for identifying and escalating protocol deviations. You may assist with assessing trends for safety and protocol deviations and communicating this to the study team and study manager. You manage organization, preparation, ordering, and set-up supplies and equipment for the Mesa site. You act as the quality control SME for study-related documents and are accountable for their correct distribution. You provide training to study staff and subjects. You communicate effectively and professionally with coworkers, leadership, and study subjects. You collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders. You perform other duties as assigned. What makes you successful: Bachelor's degree in life sciences or a related field. A minimum of 10 years of clinical affairs and clinical operations experience in medical devices, Clinical Research Organization and/or pharmaceutical sectors. Comprehensive knowledge of clinical trial design, regulatory requirements, GCP standards, quality assurance, and risk management. Must hold an active license to practice healthcare and able to act as Principal Investigator (RN, MD, Pharm.D…) Demonstrated ability to lead and manage clinical teams globally. Exceptional communication and interpersonal skills, facilitating effective collaboration across different cultures. Strong project management capabilities, underpinned by meticulous organizational skills and an unwavering attention to detail. Proficiency in relevant clinical trial software and data management tools. Fluency in English; proficiency in additional Asian languages is a notable advantage. (Reading, Writing, Dialect) Familiarity with continuous glucose monitoring devices and diabetes management is a plus. You are a proactive, energetic, and self-assured professional with high personal integrity and the ability to develop and maintain strong interpersonal relationships. You are an analytical, strategic thinker with leadership ability and a style that demonstrates professionalism and earns respect. Your organizational skills and attention to detail are exceptional. Your experience in continuous glucose monitoring (CGM) is considered a plus. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: (Highlight the appropriate range) 0-5% 5-15% 15-25% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Responsibilities

The Clinical Research Associate will lead and conduct clinical studies from start-up to closure, ensuring compliance with protocols and regulatory standards. They will also supervise a team, develop study materials, and manage clinical tasks to meet timelines.