Responsible for organizing, communicating and evaluating team objectives for clinical studies
Participates in study design and study preparation activities
Development of clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions
Participates or leads the process to evaluate and select potential investigators and sites
Participates or leads the process to evaluate and select potential vendors as applicable
Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
Develops site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct
Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
Manages project timelines and vendor performance to meet departmental and corporate goals
Monitors and tracks clinical trial progress and provides status update reports
Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable
Oversee work and performance of clinical team members, including coaching and supporting any direct reports. Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG)
Analyzes and evaluates clinical data gathered during research
Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application.
Responsible for authoring internal documents, clinical study reports or clinical evaluation reports
Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions
Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT
Coordinates and manages Investigational Product including overall accountability and reconciliation
Responsible for selection of CRO study staff and coordinating training including documentation
Leads the review of clinical data at the CRF, data listing, and report table levels
Represents Clinical Affairs at the Project Team level for individual studies, as appropriate
Identifies and escalates site, vendor and study related issues to supervisor, as appropriate
Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. Working knowledge of CEC and DSMBs.
Manages training of investigators, site staff, and SWMI clinical staff.
Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
Other duties as assigned.
Qualifications
Bachelor’s Degree in a scientific field of study although we may consider other degree emphasis.
Medical device experience strongly preferred
Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred.
Previous experience directly managing others or equivalent experience
Ability to travel 10-20% domestically and internationally
Thorough knowledge of Good Clinical Practice (GCP) is required
Working knowledge of GCP, FDA, ISO and other applicable regulations
Experience with EDC Data Management Systems
Basic understanding of peripheral and coronary artery disease and therapies preferred
Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running IDE trials
ACRP or SOCRA clinical research certification preferred
Able to manage multiple project teams
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements
Must have excellent verbal and written communication skills
