Design-Jobs in Malaysia

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.

Summary

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 provided areas 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.

Essential Duties And Responsibilities

• Lead, assist and conduct clinical studies from start up to closure.
• Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision.
• Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.).
• Assists management with departmental audits of clinical studies and procedures.
• Collaborate with project management, individual contributors and direct manager to establish and maintain study timelines
• Clearly demonstrate understanding of clinical study management/prioritization
• Manage all clinical tasks and deliverables to meet clinical timeline
  
  

• Supervise a team of Clinical Research staff who will execute clinical studies
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and Dexcom policies and procedures
• Create training strategies
• Ensure staff are delegated and trained appropriately and documented
• Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.
• Establish KPI and benchmark metrics to measure responsible tasks, improve quality in the conduct of the studies, and lead continuous improvement initiatives
  
  

• Partner with Clinical Affairs management and direct reports to develop and execute clinical studies.
• Write and/or review assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
• Incorporate understanding of study objectives and key data points when planning for each assigned protocol
• Execute and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom’s SOPs
• Work with direct reports to execute assigned clinical trials including start up, subject recruitment & scheduling, collection of regulatory documents, conducting study visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports.
• Responsible for identifying and escalating safety events
• Responsible for identifying and escalating protocol deviations
• May assist with assessing trends for safety and protocol deviations and communicating this to study team and study manager. Maintain organization, preparation, ordering, and set-up of supplies and equipment for the Mesa site.
• Quality control SME for study-related documents and be accountable for their correct distribution.
• Provide training to study staff and subjects.
• Communicate effectively and professionally with coworkers, leadership, and study subjects.
• Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
• This position assumes and performs other duties as assigned.
  

Experience And Education Requirements

• 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.
  
  

Preferred Qualifications

• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop and maintain good interpersonal relationships
• Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
• Excellent organizational skills and attention to detail.
• Experience in continuous glucose monitoring (CGM) is a plus.
  
  

Travel Required

• 0-30%.
• Local to MY and willing to travel to San Diego, CA and/or Mesa, AZ as needed.
  
  

Supervisory Responsibilities This job has supervisory responsibilities. Up to 3 direct reports.

Language Skills: Ability to read, analyze, and interpret general business correspondence and governmental regulations. Ability to write basic reports, emails, and transcribe notes either orally or handwritten Ability to effectively present information and respond to questions from managers, clients, customers, and the general public. Ability to effectively interact with international customers and their local customs as needed. Writes/reviews protocols, study reports, and other materials. Apply negotiation skills, manage Dexcom-Sponsored partners and critical business assets when needed.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, and ability to adjust focus.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate. The work environment may include collaboration with and/or supervision by remote employees, so excellent communication, independence, self-drive, and discipline skills are required.

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.