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Iqvia Biotech
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Clin Project Manager

Clin Project Manager

Iqvia Biotech

1 - 4 years

5 - 9 Lacs

bengaluru

Posted:2 days ago| Platform:

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Skills Required

risk management project management resource customer service presentation skills problem solving excel change control clinical research vendor writing leadership project delivery performance management powerpoint communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manage end-to-end delivery of testing services for single/multi-service projects.
Ensure timely and budget-compliant delivery of high-quality results.
Provide comprehensive testing expertise to the testing team.
Lead project planning, execution, and close-out activities.
Comply with Good Clinical Practices (GCPs), regulatory guidelines, SOPs, policies, and CDM guidance documents.
Attend kick-off meetings and regular project meetings until study go-live.
Take full responsibility for creating Edit Checks Test Plan documents and writing test cases, releasing them to the testing team for testing activities.
Review Project Plans and escalate issues to all stakeholders; comprehend study protocols and share basic requirements with validation project teams.
Perform eCRF and Time & Events QC according to the QC checklist, review ASB and Edit Specification documents, providing input and escalating issues if any.
Document changes made to Edit Specifications within the Test Plan during validation in version history and request final, authorized versions of documents for system configuration validation.
Provide project status updates on validation activities to Data Team Lead/Lead Programmers and review Testing Comments Log after each cycle of testing, providing it to programmers.
Document all testing documentation in eDMSF in a timely manner and coordinate regularly with internal customers, establishing strong communication.
Work with functional managers to ensure appropriate resources are assigned to meet project deliverables and implement proactive quality management plans across multiple projects/programs.
Track service performance and provide leadership to identify root causes of issues and implement remedial actions, continuously seeking opportunities to improve processes and working with teams to develop and implement plans to reorganize and drive change across multiple projects/programs.
Ensure timely follow-up and resolution of compliance issues, serving as a Subject Matter Expert (SME) for the validation group and training/mentoring testing team members.
Conduct Quality Reviews as applicable and review QIP for budget allocation, communicating any out-of-scope activities.
Review individual project financial performance and communicate issues to stakeholders, ensuring adherence to study budgets.
Supervise implementation of new technology and serve as the primary point of contact for internal customers on testing deliverables, justifying and performing direct negotiations regarding timelines, financial aspects, process, and resources.
Develop and maintain strong customer relationships.

Job Requirements

Bachelor's degree in Science/Computer Science/Information Technology or Bachelor in Technology.
Minimum 6 years of relevant clinical DB testing experience in CDMS platforms.
Strong knowledge of clinical research services and healthcare intelligence.
Excellent leadership and communication skills.
Ability to work in a fast-paced environment and meet deadlines.
Strong analytical and problem-solving skills.

About Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .

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Clin Project Manager