Lead Clinical Data Manager

May 18

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Medrio

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Accelerate clinical research with the fastest, easiest, and most flexible eClinical tools.

Electronic Data Capture (EDC) • eClinical • Electronic Case Report Forms (eCRF) • Electronic Patient-Reported Outcomes (ePRO) • Data Management

51 - 200

💰 $30M Venture Round on 2017-05

Description

• The Lead Clinical Data Manager (LCDM) is to be the subject matter expert pertaining to eCRF design, data management guidelines, and database creation. • Responsible for all clinical data management activities in compliance with Standard Operating Procedures (SOPs) and current industry/regulatory guidelines. • Coordinate deliverables on assigned projects depending on the relevant model and Data Management (DM) Vendor. • Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities. • Develop and review electronic Case Report Forms (eCRFs). • Manage the process of database modifications (after go-live) due to protocol amendments or study needs. • Regularly communicate and/or respond to data collection sites, third party service providers, and sponsors.

Requirements

• A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company. • In-depth understanding of database structures and database programming. • In depth knowledge of CDISC SDTM/CDASH standards. • In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM). • Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A. • The proven ability to provide leadership and think strategically to achieve business goals. • Strong analytical, problem-solving, and technical skills in database programming. • Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Knowledge of at least one computer programming language is an asset. • Must have strong communication (both verbal and written), interpersonal, and client services skills. • Must be highly organized and self-motivated.

Benefits

• 25 Days Holiday + Bank Holidays • Pension • Gym Membership contribution • Private medical cover • Remote working