Senior Clinical Trial Manager

The Senior Clinical Trial Manager (Senior CTM) plays a key role in leading Glooko’s Clinical Research projects. The Senior CTM will manage existing clinical projects and should have specialist knowledge of applicable regulations, nationally and internationally as appropriate. The Senior CTM will provide operational management skills in the planning and execution of multiple studies. 

 

Areas of Responsibility: 

• Responsible for supporting external, internal, decentralized, and virtual clinical trials and registries.  
• Responsible for ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
• Leading operational aspects of clinical trials, including the development of study and source materials (SOPs, IRB forms, etc.).
• Supporting internal departmental quality compliance.

 

Core Responsibilities: 

• Manage multiple ongoing clinical research studies. 
• Coordinate clinical study materials, including scope definition documents, study procedure guidelines, informed consent forms, IRB submissions/approvals, monitoring plans and tools, case report forms, data management plans, safety plans, close-out plans, and clinical study reports.
• Responsible for developing and implementing training for study sites.
• Ensure compliance with SOPs and regulatory requirements (e.g., GCP and US and OUS guidelines).
• Work closely with the Customer Support, Product/Engineering, and Data Science teams to ensure the quality of clinical trials. 
• Responsible for ensuring trials are ready for audit. 
• Coordinate activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
• Participate in project and departmental team meetings. 
• Participate in meetings with customers and partners as needed.
• Work closely with major device, pharma companies, and CROs to support external clinical research studies and Glooko’s Clinical Research Product Team, including clinical operations, data management, and auditors. 
• Track and record safety concerns and adverse events/SAEs.
• Understand diabetes and comorbid conditions.

 

Qualifications and Requirements: 

• Excited to work on a team that cares deeply about helping those living with chronic conditions.
• Advanced  degree in a health-related field is preferred with 7+ years of experience in clinical trials.  
• Clinical research certification from DIA, ACRP, or SOCRA is preferred.
• Experience with running decentralized or virtual trials using remote data collection tools like wearables, devices, smartphones.
• Strong knowledge of the clinical research process including working knowledge of all functional areas of clinical trials. 
• Excellent organization and customer service skills and is comfortable communicating with key stakeholders internally and externally.
• Possess problem-solving skills, attention to detail, and resourcefulness; respect and responsibility are critical to success in this role. 
• Broad understanding of applicable Good Clinical Practices (GCP), International Conference of Harmonization (ICH), and Code of Federal Regulations (CFR).
• Able to work independently to manage clinical tasks and deliverables to meet timelines with a customer service orientation. 
• Strong interpersonal and communication skills across all levels of the organization. 
• Ability to collaborate cross-functionally with internal and external key stakeholders including the clinical studies team, data management, clinical site investigators, global clinical, and other internal customers.
• Commitment to individual and team success.
• Is responsive and approaches work with a bias for action. Will thrive in a fast-paced, changing environment with limited structure that requires flexibility, resourcefulness, efficiency, and communicate effectively in a remote environment.
• Travel for customer meetings and conferences may be required for up to 10%. 

 

About Glooko:

There are over 420 million people in the world with diabetes and Glooko helps them, as well as their physicians and care team, manage the disease more easily and cost effectively. Glooko is the Unified Platform for Diabetes Management and provides an FDA cleared, HIPAA compliant Web and Mobile (iOS and Android) application for people with diabetes and the clinicians who treat them. The platform seamlessly unifies data from over 80 of the leading blood glucose meters, insulin pumps, continuous glucose monitors, activity trackers, and biometric devices to deliver insights that improve personal an