• Lead a team of clinical professionals to deliver quality clinical research oversight and results• Foster relationships & collaborate with clients to support clinical trial needs• Provide guidance on clinical site selection dependent on study design• Oversee clinical trial activities from site qualification, initiation, monitoring, through study completion • Mentor clinical personnel of varying backgrounds • Work with clients to provide GCP oversight and compliance to existing clinical departmental procedures

• Foster relationships & collaborate with clients to support clinical trial needs• Provide guidance on clinical site selection dependent on study design• Oversee clinical trial activities from site qualification, initiation, monitoring, through study completion • Mentor clinical personnel of varying backgrounds • Develop study protocols and operating procedures to uphold study integrity• Review clinical trial data to support clinical study reporting • Manage clinical trial resources and timelines in coordination with project teams

• Manage clinical trials from site qualification through study completion and site closure, in compliance with applicable regulations and standards • Develop study protocols and departmental SOPs • Prepare clinical study final reports• Supervise collection and tracking of clinical study specimens• Monitor adherence to protocols during clinical studies and determine study completion• Interact with internal and external groups to facilitate completion of studies for IVD regulatory submissions• Present clinical study status updates to management

• Day-to-day hands-on work associated with in-house clinical studies• Collection and analysis of experimental data generated in-house and externally• Prepare monitoring reports and letters per defined timelines • Collect and ensure completeness of all essential regulatory documentation from sites from study start-up through close-out• Reconcile site regulatory binder and file documents as needed• Train and provide technical support to external sites• Mentor entry-level team members in departmental procedures and regulations

• Management of clinical samples used to support regulatory submissions• Acquisition of samples from external clinical sites to build the sample bank• Interdepartmental requests for clinical samples • Maintain electronic database of all clinical samples

• Manage inventory and logistics of shipping supplies and samples to external testing sites• Assist in preparation and qualification of samples for internal clinical validation studies • Departmental document creation and control• Regulatory departmental support through document preparation and compliance matters