Sr. Clinical Study Manager

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled... development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

About This Role:

We have an exciting opportunity to join our clinical team at Veranex! The ideal candidate will be responsible for organizing clinical studies and local teams for clinical studies. This individual will ensure studies are conducted in accordance with applicable requirements, study protocol, contract, and clients? expectations.

What You Will Do:
? Responsible for the day-to-day management of clinical project activities and deliverables.
? Serves as a liaison with stakeholders across all functional areas of the project.
? Manages study budget and timelines.
? Manages vendors and study committees (CECs, DSMBs), including the implementation and coordination of scope of work.
? Responsible for the maintenance of clinical and regulatory files, with accurate and timely tracking and documentation.
? Oversees the development of clinical reports supporting regulatory submissions.
? Coordinates and supports all aspects of execution of clinical studies, including study planning, site identification and qualification, regulatory authority and ethics committee submissions and approvals, site contracting and budgeting, site initiation and management, monitoring, and close-out activities.
? Identifies and establishes the suitability of study investigators and their investigation sites and liaises with them to ensure compliance with all necessary study requirements, approvals, and agreements (e.g., financial, and confidential).

Qualifications:Required Skills: ? Bachelor's Degree in health sciences or related discipline, plus 7-10 years of relevant work experience ? In-depth understanding of clinical research operations including GCP, regulatory requirements and operational procedures ? Excellent written and oral communication skills ? Excellent organizational, decision-making, and time management skills ? Excellent attention to detail ? Ability to multi-task and perform a wide range of activities ? Ability to work under a timeline and budget ? Ability to solve complex problems ? Advanced ability to effectively manage multiple tasks and projects ? Ability to lead and coordinate cross-functional teams

Preferred Skills:
? Experience working in a consulting/services environment
? Medical device background

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics

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