Clin Process Spec 2

2 weeks ago

Bengaluru Karnataka, India IQVIA Full time

Role: An exciting opportunity to contribute to the development of first-in-class specialty medicines for patients in need within our healthcare division. You will be part of an established team that supports study teams across Phase I to Phase IV (both interventional and non-interventional) and Investigator Sponsored Studies, with or without CRO involvement. As a Clinical Trial Coordinator, you will oversee activities within a dedicated Center of Excellence, ensuring the operational success of clinical studies while collaborating with multiple cross-functional teams and CROs.

**Responsibilities**:

- Collaborate closely with clinical teams, offering support and specialized knowledge to ensure the successful and timely execution of clinical studies, while leveraging insights from senior leadership.
- Oversee and perform updates to the Clinical Trial Management System (CTMS) and associated databases, ensuring data integrity and compliance.
- Generate comprehensive reports, graphs, dashboards, newsletters, and data models to facilitate team meetings and enhance the decision-making process.
- Analyze diverse data sets, identify emerging data types, and synthesize information into actionable metrics and insights.
- Monitor data quality, proactively identify inconsistencies and risks, and implement corrective actions.
- Manage system access and ensure appropriate oversight of study resources, optimizing resource allocation and usage.
- Assisting and mentoring junior staff

Qualifications:

- Graduate background (e.g. Bachelor’s degree) in scientific field plus substantial relevant professional experience (5 years or more in Clinical Development or equivalent) and very good knowledge and experience in own discipline and beyond
- Exceptional oral and written communication skills in English.
- Proven ability to thrive in an international, multicultural, and cross-functional matrix environment.
- Strong understanding of Clinical Operations policies and procedures, as well as ICH-GCP guidelines.
- Proficient in utilizing CTMS across all functionalities, ideally as a CTMS Super User.
- Highly experienced in generating reports from various IT systems, such as CTMS and Spotfire.
- Capable of effectively collecting and analyzing large-scale data sets from various sources for reporting purposes.
- Excellent qualitative and quantitative analytical skills.
- Ability to streamline and automate processes for increased efficiency.
- Proficient in computer skills, including advanced knowledge of MS Office (Word, PowerPoint), Outlook, and TEAMS.
- Highly experienced in Excel, including Text, Date & Time, Lookup & Reference, Statistical Functions, and Pivot Tables.
- Strong administrative, coordination, and problem-solving abilities.
- Excellent time management and prioritization skills, with the capacity to work independently and efficiently under pressure.

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