Clinical Data Engineer II

Key Accountabilities:

Accountability

Supporting Activities

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 eCRF’s following SOPs and internal process guidelines.
• Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to by:
• 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 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
• 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 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

• Prepare for and participate in Bid defense meetings
• Independently support with 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, etc.)
• Communicate updates to standards with database programming team. Coordinate updates as required

System Ownership

• Act as System owner or deputy system owner
• Manage vendor and business requirements

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
• Excellent negotiation skills and ability to influence in order 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 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
• Advanced presentation skills
• Time management and prioritization skills in order 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