Clinical Database Specialist

4 days ago

Hyderabad, Telangana, India Parexel Full time
Job Purpose

The Senior Clinical Database Programmer will provide technical expertise for the conduct of clinical trials, acting as an internal subject matter expert in specific areas providing technical support and expert advice, and working independently to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies.

This role will assist the Database Primary or Technical Lead role on projects, liaise with sponsors, Data Management Lead and other functional areas as required. General areas of responsibility include eCRF design, edit check programming and integration of third-party systems with the EDC databases. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

Key Responsibilities

  • Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
  • Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
  • Accountable for first time quality on all deliverables.
  • Provide feedback for study programmers on the creation of eCRF's following SOPs and internal process guidelines.
  • Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to by:
  • Actively assume activities on a project as required.
  • Monitor project resourcing and identify changes in scope.
  • Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first time quality.
  • Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues.
  • Provide technical support and advice to the internal team.
  • Ability to lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously.
  • Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).

Support Projects & Technologies

  • Assist in providing technical solutions to internal or external/client enquires.
  • Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems)
  • Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized

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.
  • Maintain technical documentation that is applicable to the Clinical Database.

Support Initiatives:

  • Participate in the creation of standards, either through tools, 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

Act as a mentor and/or SME

  • Provide relevant training and 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
  • Ability to travel as required
  • Written and oral fluency in English

Knowledge and Experience:

  • 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 system used within the Clinical Trial process (e.g. SAS, CDMS, EDC: Inform, RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting) is desirable. Build Certified in at least one system, if available
  • Strong experience in 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

Education:

  • Bachelor's degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.

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