Clinical Data Lead

hace 4 semanas

Desde casa, México ICON A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

- Leads end-to-end data review activities performed on a clinical trial.
- Accountable for achieving clinical data management deliverables on-time, with high quality and to agreed financial metrics.
- Communicates trending analyses and a summary of findings to internal and external stakeholders to support the on-time delivery of data fit for analysis.

**Responsibilities**:

- Serves as the primary contact for internal and external team members regarding clinical data management data review activities and leads these review activities to ensure the delivery of data fit for analysis.
- Provides input into clinical system development activities, to ensure systems support the data review needs of the study, focusing on critical data and processes, and identified risks.
- Ensures clinical data management review requirements are put into production per the study’s protocol risk evaluation and integrated data review plan (IDRP), and that ongoing data review activities are compliant with study plan requirements.
- Contributes to the development and maintenance of study plans documents specifying data review strategy and applicable procedures on assigned protocols/projects, including but not limited to data management plan.
- Develops and oversees timeliness of clinical data management activities during the life cycle of studies as it relates to data review and data delivery milestones.
- Centrally reviews clinical data at aggregate level, using analytic reporting tool(s) to support the identification of risks and data patterns/trends. Mitigates risks by using signal detection and quality indicators.
- Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
- Proactively identifies out-of-scope clinical data management activities to the study project managers to be implemented in required change orders.
- Leads and hosts the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful way such as summarizing the data and representing the information visually.
- Leads clinical data management activities on more complex projects with diverse scope.
- Accountable for creating and maintaining clinical data management timelines, to oversee and achieve high quality interim and final contractual deliverables for more advanced projects.
- Using detailed knowledge of the protocol, identifies critical data and processes from protocol review, and supports protocol risk evaluation process.
Works with assigned project teams to communicate, address and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety or study analysis.
- Trains and mentors new and less experienced team members.
- Participates in sponsor and/or third party audits.
- Develops tools/analytics used to monitor compliance and identify trends.
- Actively seeks new business opportunities with assigned clients and collaborates with internal colleagues for new business initiatives.
- Develops and maintains data review study documentation as appropriate to facilitate data validation and analytics.
- Identifies root cause to systematically resolve complex data issues.
- Sets expectations and ensures consistency in data review approach and compliance and identifying trends.
- May help to write articles for industry publications and give presentations at industry conferences.

To be successful in the role, you will have the following basic qualifications:

- Bachelor’s degree in quantitative, scientific or health related field required.*
- 8 years of relevant experience required.
- Knowledge and/or understanding of analytic open source and/or enterprise level ETL and Analytic tools and practices
- Sound knowledge of analytic modeling methods such as regression, classification and clustering
- In-depth knowledge of the drug development process including risk-based monitoring principles, clinical and biometrics procedures, workflows, and software systems.
- Expertise in interpreting protocols and identifying risks and appropriate mitigation strategies for clinical studies
- Excellent project management and leadership skills
- Excellent written and verbal communication and presentation skills
- Ability to work collaboratively and effectively in a cross-functional and culturally

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