Sr Clinical Trial Lead

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Meet the team:

As the most senior most Clinical Trial Lead (CTL), this position will—in partnership with the Director of Clinical Operations—provide vision and support for the role of Clinical Trial Lead.  They may provide mentorship and training.  They will lead business-critical or novel/challenging studies and teams.

• The Sr. CTL will support the greater vision for the CTL role, including prioritizing and leading initiatives to strengthen/optimize the role.  Create and implement training programs. 

• The Sr. CTL will be responsible to mentoring junior staff in the CTL role as well as reviewing and supporting their key deliverables.

On an individual study basis:

• The Sr. CTL will establish, track, and deliver clinical operations milestones across multiple and/or complex programs.  

• The Sr. CTL will provide direction and leadership to the clinical operations study team and manage daily clinical operations planning, management, and execution of deliverables.

• Sr. CTL is the single point of accountability for all stages of clinical operations activities, from early study design, start-up, active study, and close-out.

• Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines, budget, and milestones.

• Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations, as well as software, tools, and systems used in clinical conduct (e.g., CTMS, eCRF, TMF, etc.)

Where you come in:

• Execute clinical operations deliverables for Dexcom products

• Lead clinical activities, directing, and leading the study team as above in alignment with business goals, objectives, milestones, and timelines,

• Collaborate with Clinical Affairs management, Clinical Program Management, Clinical Science, Clinical Supply/Logistics, Compliance, and the various functional groups (R&D, Biometrics, Medical Affairs) as well as external contacts (study investigators and research coordinators)

• Identify risks that may impact the overall project plan and initiate contingency plans as appropriate

• Develop/Revise and/or provide input in the development of clinical trial related documents including but not limited to:

  • Study protocols, training materials, case report forms, informed consents, IRB submissions, source documents, timelines, clinical monitoring plans, reference manuals, supply listings, monitoring tools, presentations, meeting materials (agenda and minutes)

• Lead functional strategy discussions, study meetings, and alignment meetings as needed

• Function as a Subject Matter Expert

• Work independently to manage all clinical tasks and deliverables with little to no oversight

• Assists management with departmental audits of clinical studies and procedures

What makes you successful:

• Extensive experience in all aspects of clinical trial design and execution

• Thorough understanding of the processes associated with study preparation, study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations

• Technical expert in the various aspects of the clinical evaluation process

• History of significant contribution to the success of planning and executing clinical strategies in support of product clearance

• Strong interpersonal and communication skills

• Excellent organizational skills and attention to detail

• Ability to manage multiple priorities

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.