Principal Clinical Database Programmer

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

The Principal Clinical Database Programmer will be recognized as a subject matter expert providing technical support and expert advice to internal and external addition the Principal Clinical Database Programmer can fill the Database Primary (late phase) or Technical Lead role on projects; liaise with sponsors Data Management Leads and other functional areas as required. General areas of responsibility also include eCRF design edit check programming and integration of third-party systems with the EDC databases. Further the Principal Clinical Database Programmer will monitor quality timelines resource allocation and productivity in relation to budgets. All tasks should be performed in accordance with corporate quality standards SOPs/Work Instructions/Guidelines ICH-GCP and/or other international regulatory requirements.

Key Accountabilities:

Set-Up Maintain Revise Close-Out Electronic Data Capture Systems

• 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 eCRFs following SOPs and internal process guidelines.

• Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to.

• Coordinate and lead a programming team to successful completion of a study within given timelines and budget.

• 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 regarding 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 enquiries.

• 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 regarding 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 efficiency.

• Lead or drive global initiatives (related to processes or new tools/technologies).
  

Act as a mentor and/or SME

• Provide create and implement relevant training for 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 enquiries.

• Maintain and expand local and international regulatory knowledge within the clinical industry.
  

Support Business Development

• Prepare for and participate in Bid defense meetings.

• Independently support ideas around technology and database setup to help drive winning new business.
  

Account Leadership

• Point of contact for clients and within Parexel for database programming specific matters.

• Create and maintain partnership training standards in applicable system (MDR RAVE).

• Communicate updates to standards with database programming team. Coordinate updates as required.
  

Skills:

• Excellent 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 negotiation skills and ability to influence them to achieve mutually beneficial results.

• Excellent interpersonal oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach.

• Learning ability and knowledge sharing approach; swift understanding of technologies and new processes.

• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.

• Customer focus on interacting 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 to meet objectives and timelines.

• Highly developed 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:

• 8 Years of experience in Clinical Data Programming.

• 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 ICH-GCP 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 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 21 CFR Part 11 and other relevant ICH/regulatory guidelines.

• Team and Project leadership experience required.

Education:

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