Principal Clinical Database Programmer

1 week ago

Remote, India Parexel Full time

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
- multiple projects simultaneously.- Lock/Unlock databases in accordance with guidelines and SOPs. Approve

changes made to databases (as required).
- Support Projects &
- Technologies- 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.- 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 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
- Proficient presentation skills
- Time management and prioritization skills in order to meet objectives and timelines
- Highly develop

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