Senior Clinical Database Programmer

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Provides technical expertise for the conduct of clinical trials. • Acts as an internal subject matter expert. • Works independently to support various programming activities related to clinical systems. • Assists the Database Primary or Technical Lead role on projects. • Liaise with sponsors and functional areas as required. • Responsible for eCRF design, edit check programming, integration of third-party systems. • Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems. • Lead and supervise to build and maintain database set-up for clinical data management systems. • Accountable for first-time quality on all deliverables. • Provide input into and negotiate database setup timelines. • Interact with Sponsors and Data Management Leaders regarding programming related issues. • Support projects and technologies by providing technical solutions. • Maintain technical documentation for clinical databases. • Support initiatives for creating standards and improving processes. • Act as a mentor and/or subject matter expert.

Requirements

• Strong ability to lead and collaborate with global teams and work independently. • Motivate/guide virtual teams across multiple time zones and cultures to work effectively. • Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach. • Swift understanding of new systems and processes. • A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments. • Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust. • Commitment to first time quality, including a methodical and accurate approach to work activities. • Proficient presentation skills. • Time management and prioritization skills in order to meet objectives and timelines. • Proven problem-solving skills including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses. • Ownership and accountability relative to Key Accountabilities in Job Description. • Good business awareness/business development skills (including financial awareness). • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial. • Demonstrate commitment to refine quality processes. • Ability to travel as required. • Written and oral fluency in English. • Experience in at least one programming environment (e.g. SAS, CDMS, EDC, SQL, VB, Java). • Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. • Experience working with at least two systems used within the Clinical Trial process (e.g. SAS, CDMS, EDC: Inform, RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting) is desirable. • Strong experience in the clinical research industry or similar field is required. • Knowledge of Software Development Life Cycle (SDLC) methodologies. • Knowledge of GCP, 21CFRPart11 and other relevant ICH/regulatory guidelines.