Principal Clinical Data Project 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.  

General Summary

Provides a full spectrum of support for clinical data project activities. Responsible for the successful planning, implementation, and execution of contracted services. Manages cross-functional teams and client expectations to achieve client satisfaction.

Primary Responsibilities

• Acts as liaison with client and manages client contractual, organization, and relationship needs/expectations. Ensures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and company policies and procedures.
•  Coordinates with functional leads and managers to optimize performance and utilization of project team members.
• Achieves project quality by identifying quality risks and issues, responding to issues raised by project team members, and planning/implementing appropriate corrective and preventative action plans.
• Manages scope, schedule, and quality requirements of assigned clinical data project.
• Fosters strong client relationships at the project level to promote client retention and boost prospective business opportunities.
• Ensures timely completion of all clinical data project status reporting.

Other Responsibilities

• Takes a lead role in identifying issues and risks related to clinical data project activities. Leads the presentation of project risk reviews and is accountable for action item follow-up.
• Oversees daily activities of the project team and provides direction and
• Liaises with clinical data functional leads to provide data to create project performance metrics and initiate performance-measure improvements as needed.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations,
• Provides leadership, training, guidance, and support to other clinical data staff.
• Supports business development activities by providing project information and intelligence on potential prospective business opportunities.
• Participates in audits and inspections and responds to audit findings.
• Acts as Subject Matter Expert (SME) for various technologies or processes.
• In-depth knowledge of clinical trial life cycle
• In-depth knowledge of regulatory compliance requirements
• In-depth knowledge of clinical data project processes and each function as it relates to clinical data
• Excellent written and oral communication skills
• Excellent attention to detail
• Ability to solve complex problems
• Advanced ability to effectively manage multiple tasks and projects
•  Ability to lead and coordinate small teams

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.