Hyderabad, Telangana, India
Information Technology
Full-Time
Parexel
Overview
Key Accountabilities
Manage Projects & Technology:
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).
- 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.
- 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.
- 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 Bid defense meetings.
- 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.
- 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.
- Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience.
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