Clinical Study Manager

The Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This position works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders. Understands business environment and relates extensive knowledge of internal and external activities to trends. Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

 

 

•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.

 

 

Minimum education and experience:

•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)

•Field experience preferred

•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

 

 

•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.