Clinical Research Supervisor

6943277

**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
- 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.
- 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.

Pay: RM8,000.00 - RM10,000.00 per month

**Benefits**:

- Professional development

Work Location: In person