Clinical Logistics Manager
Background
TrialSpark is a software and technology company based in NYC that helps accelerate the discovery of new drugs and medical treatments by reimagining the clinical trial process. We are building a network of our own clinical trial sites and are looking to hire clinical research coordinators who want to join us on our journey to make clinical trials more efficient.
Job Description
The Clinical Logistics Manager role is critical to the success of the studies TrialSpark is engaged in. The role will be responsible for central oversight of temperature monitoring and IP management at TrialSpark. The Clinical Logistics Manager would partner closely with the clinical operations team, study teams, and technical operations to ensure all sites in the network are monitoring temperature based on protocol specifications. The role will also partner closely with study teams to oversee day to day management of IP.
Duties include but are not limited to:
- Central oversight of temperature monitoring and site drug inventory, managing all day to day temperature operations
- Process development and oversight for temperature monitoring and site drug inventory
- SLA and KPI designer/expectation setter: creates and tracks core metrics
- Workflow architect: identifies/corrects inefficiencies in existing workflows while simultaneously designing/implementing new ones when necessary
- Partner with TechOps, Data, Engineering, and Product to establish and manage a scalable process central temperature management
- Partner with study teams to manage central site drug inventory
- Oversee the set up of temperature monitoring at all sites in the network
- Partner with Quality Assurance to establish and manage robust training for IP management best practice
- Partner with Field Operations team for equipment installation, validation/calibration, and preventative maintenance that houses IP
- Maintains open lines of communication with the study teams and field operations team to ensure study equipment meet the required standard
Qualifications and Skills:
- Demonstrated ability to handle multiple competing priorities and grow a performance-based team
- Strong organizational, analytical, and problem-solving capabilities
- Exceptional communication skills, both verbal and written, and interpersonal and relationship building
- Ability to work under pressure within tight timelines
Required education and experience
- Minimum 5 years of project management/process improvement experience
- Clinical supply and/or logistics experience
- Experience streamlining operational processes
- Knowledge in FDA and regulatory auditing of investigational drug studies
- Knowledge of clinical logistics systems for inputting and tracking IP shipments, temperature excursions, and product expiry
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.