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Principal Clinical Applications Analyst

3.00 to 7.00 Years   Bangalore   13 Oct, 2020
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Responsibilities

  • Experience implementing clinical applications, including testing and validation.
  • Leads unit and integrated testing of the software to ensure that the design objectives are met, including the development and validation of testing scripts.
  • Leads needs assessment, software design, implementation, support, and reporting.
  • Independently facilitates design of clinical workflow in conjunction with the clinicians and provides guidance to more junior analysts in designing improved efficiencies, solving complex workflow issues and incorporating quality initiatives.
  • High degree of understanding of clinical operations business processes.
  • Troubleshoots application issues, with/without vendor assistance, to resolution.
  • Troubleshoots system hardware, as needed.
  • Partners with end users to understand workflow and business processes.
  • Maintains system security for assigned applications.
  • Acts as the team project lead in partnership with the Project Management Office (PMO) on all phases of a project; from scoping and design through implementation and transition to operations.
  • Provides input to components of development of end-user training materials and participates in training efforts.
  • Leads escalation of issues with appropriate internal resources, to resolution.
  • Develops policies and procedures in collaboration with clinical operations, other Clinical Application Analyst team members, and PMO.
  • Independently leads application upgrades and troubleshooting efforts and provides guidance to Clinical Application Analysts.
  • Creates reports and assigns work problem tickets to Application Analysts.
  • Evaluates and maintains appropriate system documentation.
  • Collaborates with other clinical and application analysts to insure system integrations.

Working Relationship:

  • Reports to the Manager, Program Management Office and Application Support or designee.
  • Collaborates with Project Management, Clinical Operations staff, QA and other POI departments.
  • Supervises assigned direct reports and/or more junior team members if assigned.
  • Liaises with vendor
Qualifications
  • Bachelor degree, preferably in Computer Science/Business Management/Biolgical Science or equivalent on job work experience required.
  • Strong Computer Skills a must.
  • Has experience and/or familiar with clinical applications such as:
    • CTMS
    • EDC
    • eTMF
    • Safety Database
    • SAS
    • QMS
  • Proficiency in MS Office and internet applications required.
  • Minimum of 4 years of experience in the clinical trials industry preferred.
  • Prior experience working with or managing a clinical information system preferred.
  • Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred.
  • Prior SQL/Relational Database experience preferred.
  • Service oriented approach, flexible and proactive.
  • Must have superior attention to detail and excellent oral and written communication skills.
  • Self-driven, ability to get the job done with little supervision, can-do positive attitude.
  • Ability to problem-solve.
  • Ability to excel in a team environment.
  • Must have the ability to work under pressure with multiple competing priorities.
  • Must have strong time management, and organizational skills.
  • Prioritizing workload to the changing needs of the day to day business is also a critical skill.
  • Knowledge of change control procedures and standards are a plus
  • Ability to work in strict compliance with all procedures, rules and regulations.
  • Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
  • Must be self-motivated and able to grasp new concepts quickly.
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Keyskills :
good clinical practiceproject management officems officenew conceptschange controlcomputer skillsclinical trialssoftware designtime managementbusiness processneeds assessmentquality assuranceclinical workflowproject managementprogram managem

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