· Plans and executes clinical studies/validations and leads cross-functional teams responsible for the planning, execution, analysis and reporting of assigned clinical performance studies. Applies expertise in clinical data review and statistical analysis. Initiates clinical designs, protocols and summary reports. Ensures that assigned regulatory affairs staff and contractors have appropriate knowledge of relevant analyzer and assay technologies.
· Develops and presents program strategies to ensure that the clinical programs effectively achieve the overall assay product development program objectives within approved budgets and committed timelines and in compliance with all relevant laws, regulations, guidelines and internal policies & SOPs. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path, and other key deliverables including efficiency and effectiveness of plans and staff.
· Evaluates and statistically analyzes data that is clinically/scientifically sound to confirm or deny performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements, as needed.
· Identifies, qualifies, selects, and manages external service providers. Responsible for management of vendor performance to ensure adherence to scope of work within timelines and budget at a task level. Proactively assesses potential risks to the study and proposes mitigation plans.
· Provides cost and staffing estimates for clinical projects, ensuring appropriate input from the functional teams responsible for the conduct of assigned studies. Participates in establishing and tracking of assigned study budgets.
· Supports company cross-functional strategic business integration and process improvement initiatives and special projects.
· Work independently and prioritize study related activities
·Basic Qualifications
Education:
· Bachelor of Science required in medical, biological or medical specialty.
Experience:
· Minimum 4 years of clinical study experience, (e.g., pharmaceutical, medical device, CRO) required.
· Minimum of 2 years of experience in medical device related research including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies is required.
• Master’s degree in medical, biological or closely related science.
• Certification as a Clinical Research Professional
• Budgetary experience is a plus.
• Demonstrated track record of leadership of clinical studies. Has directly led clinical studies used in FDA 510k or PMA submissions & CE declarations.
• Cardiovascular study experienced a plus but not required;
• Knowledge of regulations and standards of medical devices
• Expertise in clinical data review and statistical analysis.
• Maintain knowledge of the medical, biological and technical / analytical aspects relevant to clinical programs.
• Strong communication skills
• Experience working and collaborating with consultants and medical experts
• Experience working with CROs and CRAs
• Experience with site selection in multicenter studies
• Ability to provide critical thinking and leadership when issues arise during execution of clinical studies/validations.
• Strong client and vendor relationship management skills.
• Effective personal, interpersonal, and communication skills for a wide variety of audiences.
• Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, manages multiple projects and resources in a fast paced and changing environment.
• Experience in computer skills to include Microsoft Word, Excel and basic templates.
• Experience with electronic case-report forms (eCRF)
Specific Duties
• Management of the on-going FIH study and close the study when completed. Perform all aspects of site communications, eligibility confirmation, data collection, monitoring, and closure activities.
• Lead the planning and development of the pivotal regulatory trial which will lead to the marketing approval in the US and Europe
o Achieve deep knowledge and understanding of the clinical literature of TARV and TAVR-related cerebrovascular events and cerebral embolism
o Plan the required trials, including protocol, execution, and oversight
o Drafting and editing of protocols, patient informed consent forms and case report forms
o Work closely with the regulatory team and consultants. Be compliant with domestic and international ethics, regulations, and laws
o Communicate with the technical department, advisory board, and consultants
o Drive site recruitment strategies, data quality, and patient compliance to protocol
o Identify and communicate with potential medical services and core-labs
o Develop strong customer relationships ensuring appropriate sponsor oversight of clinical research centers
o Partner with study team to develop all study documents necessary for trial execution
o Deliver site training, updates, and study communication materials to sites
• Future studies execution will be associated with building a dedicated team and potential collaboration with CRO. These will include but not limited to site contracts, consent approvals, IRB approvals, and other research processes with sites; site payments; maintain compliance to all SOP, GCP, and regulatory processes; ensure highest level of data quality at the site including driving resolution of queries; monitor selected sites through source data verification; conduct site initiation visits, interim monitoring visits, and close out visits; drive high quality data collection to support scientific communications, clinical research, and statistics evidence dissemination strategies
• Reports to the CEO and CMO
