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- Clinical Data Engineer II
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Clinical Data Engineer II
Parexel International Corporation
China, Remote
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