Clinical Data Manager

Description:

Position Overview

The Sr. 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 multi-disciplinary team to plan, lead, and

execute the Data Management tasks required for pre and post market medical device studies.

The Sr. Clinical Data Manager has a broad, fundamental knowledge of the data management

process and can perform most required tasks with minimal guidance.

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.

• Partner within Clinical Affairs 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.

• Review and provide feedback on study data quality including providing data

management metrics, review project statement of work and identify and report to

manager any requested out of scope activities.

• Participate in the preparation and presentation of data, when applicable.

• Provide input into the development of data management SOPs, Work Instructions, and

process documents; take a leadership role in the development of assigned documents.

• Ensure clinical data in EDC is in quality to lock/unlock and freeze/unfreeze as

appropriate for interim review statistical review, and or final database lock.

• Assist in reconciling adverse event data in Safety and Clinical databases.

• Coordinate the archiving of study databases and related documents.

• Other duties as assigned.

Additional Skills & Qualifications:

Requirements

• Bachelor’s Degree- preference for a BS in a scientific field of study

• Minimum 3 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

• Must have excellent verbal and written communication skills

• High attention to detail and accuracy

** Several CDM openings across the US at different levels and therapeutic areas! For more information and direct contact, please inquire with gpacheco@ actalentservices.com