Key Accountabilities:

Manage Projects & Technology:

• Lead and implement the setup of Data Receipt Agreements with vendors by working with cross functional teams.

• Programming and setup of Import procedures to allow the ingestion of data either using SAS or alternative technology (e.g. “Workbench”).

• Programming of reconciliation checks to ensure appropriate transfer of data.

• Programming of offline listings and custom reports to allow better insights to all external data.

• Aggrege data across all sources.

• Handling Missing Values, reading raw data files, creating data structures, handling programming errors, accessing, and managing data, appending and concatenating SAS datasets.

• Review of data using created outputs with aim of providing insights to study teams and clients.

• Accountable for first time quality on all deliverables.

• Provide input into and negotiate electronic data 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.

  • Provide technical support and advice to the internal team.
    

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

• Manage the deployment of DM technology used for creation of offline listings (e.g. Workbench, SAS or R).
  

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.
  

Support Initiatives:

• Participate in the creation of standards, either through tools (e.g. SAS Macros), 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 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:

• 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.

• 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:

• Proficiency in at least one of the following (e.g. SQL, SAS, R).

• 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 systems used to aggregate data within the Clinical Trial process (e.g. SAS, Workbench, Elluminate).

• Strong experience in clinical research industry or similar field is required.
  

Education:

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