penumbrainc - Clinical Study Manager
Requirements
• Bachelor's degree in Biological Sciences or related field with 5+ years of experience, or equivalent combination of education and experience • 5+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry) • Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements. • Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight. • Excellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is required. • Ability to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneously. • Working knowledge of medical terminology required. • High degree of accuracy and attention to detail • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously • Working Conditions • General office environment • Willingness and ability to work on site. May have business travel from 5% - 15% • Potential exposure to blood-borne pathogens • Requires some lifting and moving of up to 10 pounds • Must be able to move between buildings and floors. • Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. • Must be able to read, prepare emails, and produce documents and spreadsheets. • Must be able to move within the office and access file cabinets or supplies, as needed. • Annual Base Salary Range: $123,000 - $170,000 • This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. • Working Conditions
Responsibilities
• Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions) * • Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by management. * • Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters. * • Negotiates study budgets with sites, Core Labs, and other vendors. * • Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits). * • Contributes to process improvements that help foster continuous improvement. • Helps update and maintain study trackers and dashboards. • Participates in system user acceptance testing. • Manages vendors such as Core Lab.* • Organizes and manages Investigator Meetings. • Works with data management to develop systems for and track project metrics. • Drives development, approval, and distribution of study-related documents including Case Report Forms, study manuals* • Leads activities for internal and regulatory audits. * • Monitor progress of studies, identify study-related trends/issues and with the clinical team, implements corrective actions when necessary. * • Coordinates activities associated with study start-up and management. Provides solutions to challenges such as enrollment in the clinical study. • Represents the Clinical Affairs Department on cross-functional meetings and projects as needed. • Works with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and Sales. • Attends scientific conferences and interacts with key opinion leaders. Maintains proactive communication regarding all study related activities with study PIs. • Assists management with regulatory submissions and other clinical study reports. * • Supports the study team by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations). • Mentors and trains staff regarding protocols, good clinical practice, departmental processes, etc. • Assists team members in managing challenging investigators/staff. • Assists in selection of vendors, such as Core Labs. • Travels as needed to meet project milestones. • Leads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects. * • Evaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound report. * • Drafts Investigator Meeting content. • Forecasts study timelines and budgets. * • Adhere to the Company’s Quality Management System (QMS) as well as domestic and • global quality system regulations, standards, and procedures. * • Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * • Ensure other members of the department follow the QMS, regulations, standards, and procedures. * • Perform other work-related duties as assigned. • Indicates an essential function of the role
Benefits
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
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