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Principal Clinical Data Manager

Remote:

Full Remote

Contract:

Full time

Salary:

116 - 170K yearly

Experience:

Expert & Leadership (>10 years)

Work from:

Canada, California (USA), United States

Offer summary

Qualifications:

Bachelor's Degree in a scientific field, Minimum 10 years of clinical research experience, Knowledge of Good Clinical Practice (GCP), Experience with EDC systems, Understanding of cardiovascular disease is a plus.

Key responsabilities:

Oversee global data management activities
Manage vendor relationships for data management
Execute data management and validation plans
Collaborate with Clinical Affairs and Biostatistics
Mentor junior team members and improve processes

Shockwave Medical Large https://shockwavemedical.com/

1001 - 5000 Employees

See more Shockwave Medical offers

Job description

Description

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Description

Position Overview

The Principal Clinical Data Manager is responsible for the oversight of global data management activities across the clinical study life cycle. The individual will be accountable for data management activities, oversight of multiple vendors, and for conducting studies in compliance with regulatory standards and in alignment with Shockwave Medical Inc.’s business needs. The individual will participate as an active member of a global multi-disciplinary team to execute the Data Management tasks required for pre and post market medical device studies. The Principal Clinical Data Manager has a deep, fundamental knowledge of the data management process and is responsible for multiple clinical projects or programs.

Essential Job Functions

Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
Development and execution of data management plan, case reports forms, database development, data specifications, edit checks, query logic, user acceptance testing, and data validations.
Lead data management activities in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.
Partner within Clinical Affairs and Biostatistics to streamline metrics related to clinical study execution and refine clinical data review processes to ensure oversight of clinical studies.
Participate in the review of Clinical research documents including study protocols, investigator brochure, and clinical study reports as necessary.
Work collaboratively with Clinical and Biostatistics to ensure data in EDC is of quality for Data Reviews, DSMBs, and interim or final database lock.
Assist in reconciling adverse event data in Safety and Clinical databases.
Oversee the archiving of study databases and related documents.
Proactively mentor, train, and oversee tasks of junior or new team members.
Manage and lead process improvements and the implementation of action items.
Other duties as assigned.

Requirements

Bachelor’s Degree, preferably in a scientific field of study
Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
Knowledge and experience in supporting device pre- and/or post-market clinical studies, including IDE trials preferred.
Thorough knowledge of Good Clinical Practice (GCP)
Ability to work in a fast-paced environment while managing multiple priorities.
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes.
A basic understanding of cardiovascular disease and therapies is an advantage.
Detail oriented with excellent communication skills and extensive experience working in a cross-functional setting.

Market Range:

San Francisco Bay Area (SFBA) Market Range: $136,000 - $170,000
All Other US Locations (Outside of SFBA): $116,000 - $145,000

Exact compensation may vary based on skills, experience, and location.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer