- Clinical research jobs
- Senior Clinical Data Engineer
Senior Clinical Data Engineer
Parexel International Corporation
Additional Locations: Bengaluru,Karnataka,India
Documentation· Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
Support Initiatives
· Participate in the creation of standards, either through tools (e.g. SAS Macros), libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.· Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.· Lead or drive global initiatives (related to processes or new tools/technologies).
Act as a mentor and/or SME
· Provide relevant training to staff. Provide mentorship to staff and project teams as appropriate.· Assist project teams in the resolution of problems encountered in the conduct of their daily work.· Assist in providing technical solutions to internal or external client enquires.· Maintain and expand local and international regulatory knowledge within the clinical industry.
Support Business Development
· Support Bid defense meetings.
Skills:· 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. function in an evolving technical environment.· 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.· Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement.· Excellent analytical skills.· Tenacity to work in an innovative environment.· Ability to travel as required.· Written and oral fluency in English.Knowledge and Experience:· Proficiency in at least one of the following (e.g. SQL, SAS, R).· 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.· Strong experience working with at least two systems used to aggregate data within the Clinical Trial process (e.g. SAS, Workbench, Elluminate.· Strong experience in clinical research industry or similar field is requiredEducation:· Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.
Job posted: 2023-09-21