This position is responsible for developing and implementing the business unit’s clinical research strategy and will have input into the overall business unit strategy partnering with business teams in the United States and internationally. This role will lead efforts in the design and operationalization of clinical research studies and oversee the global clinical research team.
Essential job functions:
• Implement approved clinical trial protocols and operational plans, which are consistent with strategic corporate objectives and assume primary accountability for the ongoing progress of those plans.
• Provide leadership to members of multidisciplinary project teams throughout the conduct of assigned clinical trial.Determine timelines and priorities for study sites. Monitor progress of studies, while taking an active role in ensuring timeliness of execution.
• Oversee department budget as well as propose, plan and ensure budgeting/ cost control for each study is managed, along with payments for clinical trials.
• Lead the global clinical study team.Recruit, select and ensure team engagement.Manage performance, resource allocation/prioritization, and employee development.
• Develop and review informed consent materials, clinical trial recruiting materials and HIPAA disclosures.
• Participate in cross-functional assessments of all potential clinical studies (FDA-required, “investigator-initiated” and post-market). Partner with regulatory, R&D, and marketing to determine post market surveillance strategies to meet regulatory standards and business needs.
• Evaluate and address Adverse Events, including managing the DSMB / CEC, where one is used.
• Participate in safety review activities, including recall activities to provide the clinical impact perspective.
• Assist RA in preparation of responses to FDA deficiencies on IDEs, preparation of responses to FDA deficiencies on pre-marketing submissions and in submitting protocol changes or other study-related communications including ad hoc issues, such as IRB or DSMB decisions to suspend a study.
• Keep abreast of changes on FDA policy as it relates to WMT’s business and disseminate same, changes in international requirements as well as clinical requirements in emerging markets.
• Manage KOL relationships in the area of WMT’s clinical research initiatives.
• Bachelor’s degree in a medical or related field required; advanced degree in related field preferred
• 10 years’ experience in clinical research preferably in medical device
• 10 years’ leadership experience
• Strong knowledge and continued education with ICH Guidelines on Good Clinical Practice (GCP) and Food and Drug Administration (FDA) requirements for premarket and postmarket studies
• Strong communications and interpersonal skills
• Requires strong customer focus with sites, study site staff, physicians, and consultants with responsibility for maintaining the highest level of Compliance for the entire program
• Strong interpersonal and leadership skills required
• Advanced problem solving skills