What Youll Do: Development, maintenance, and optimization of the clinical quality system, clinical regulatory requirements, and data integrity/quality Establish detailed program plans, drive program execution toward established objectives, assess risk and implement strategies to ensure successful delivery of the clinical objectives Contribute to the overall strategic direction for development and implementation of clinical affairs objectives and processes Direct and collaborate with internal and external staff to assure successful conduct of assigned clinical programs consistent with company objectives and applicable regulations and policies Development of protocols, statistical analysis plans, reports and other clinical study documentation Support and contribute to manuscripts, abstracts, data presentations, and health economic value initiatives Promote and embody culture and behavior expectations of a high-performance culture Drives leadership of issue identification and resolution. Knowledge/Skills/Abilities: Excellent verbal and written communication Ability to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in need Knowledge of ICH/GCP and FDA medical device regulations Knowledge of electronic data capture systems and web-based clinical trial management tools Knowledge of research design, data analysis and biostatistics Self-motivated and independent work style with the ability to initiate and follow through on assignments Self-assured, knowledgeable professional capable of developing good interpersonal relationships with medical professionals Excellent organizational skills and attention to detail High degree of personal integrity.