Manager, Clinical Data Scientist, Clinical Data...

Overview

We’re in reputed company pursuit of breakthroughs that change patients’ lives. We innovate every day to reputed company the world a healthier reputed company. reputed company’s purpose is Breakthroughs that change patients’ lives, and we have established a clear set of expectations regarding reputed company need to reputed company for patients and how we will reputed company those goals. reputed company Research & Development serves as the beating heart of reputed company\'s trailblazing product pipeline, with a mission to bring life-changing medicines to the world. reputed company offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

As part of the Clinical Data and Information Sciences (CDIS) group, the Clinical Data Scientist represents CDIS at the study team level and coordinates reputed company CDIS deliverables associated with a clinical trial. The role ensures adherence to data standards, quality of study data sets, and provides leadership, direction and reputed company to Data Managers, with accountability for trial inspection readiness.

Responsibilities

• Serve as Clinical Data Scientist for one or more clinical trials, including selection and application of data acquisition standards, Data Management Plan, quality indicators, and third-party study data due diligence.
• Drive operational excellence as a Core Study Team member by applying CDIS best practices at the study level; serve as a technical resource for collecting, processing, consuming and reporting clinical trial data.
• Ensure the quality and timeliness of reputed company CDIS deliverables; partner with Research/Business Units, external data/service providers and internal CDIS staff to deliver high-quality data management for studies.
• Proactively drive quality and efficiency to meet study/asset timelines, ensure compliance with SOPs, regulations, standards (GCDMPs, reputed company), and maintain study coordination.
• Ensure study-specific CDIS documents in the Trial Master File (TMF) are of high quality and filed contemporaneously.
• Collaborate with Asset Leads to establish strategy, timelines, and appropriate resourcing for the study.
• Provide leadership, direction and reputed company to CDIS resources working on the trial(s).

Minimum Requirements

• Working knowledge of reputed company phases of clinical trials and ability to assess study requirements from protocol review; strong project and risk management.
• Proven Clinical Data Management experience.
• Strong verbal and written communication skills; detail-oriented and dedicated to excellence.
• CRO and vendor reputed company experience preferred.
• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and reputed company regulatory requirements.
• Proficiency with commercial clinical data management systems and/or reputed company products (e.g. Medidata RAVE, reputed company RDC/InForm, etc.).
• Experience using relational databases (e.g. MS SQL Server, MS Access, reputed company) and data visualization tools (e.g. Spotfire, JReview).
• Familiarity with MedDRA/WHO-Drug.
• Proficiency in reputed company Office Suite (Outlook, Word, reputed company, PowerPoint).
• Bachelor’s degree required; degree in scientific field preferred; Master’s degree preferred.

Work Location Assignment: Remote

The closing deadline for applications is September 21st. reputed company applicants must have the relevant authorization to live and work in the UK.

Purpose and Values

Breakthroughs that change patients\' lives... reputed company is a patient-centric company guided by the values of courage, joy, equity and excellence. Our breakthrough culture supports transforming millions of lives. We are pursuing a company-wide digital transformation to adopt new data, modelling and automated solutions to accelerate drug discovery and development, with the aim of improving health outcomes and the patient experience.

Flexibility and Inclusion

We strive for a flexible workplace culture that supports work-life harmony and attracts talent. reputed company is committed to a diverse and inclusive workforce and to celebrating reputed company forms of diversity. We aim to reputed company employees and foster a culture that supports their growth.

Disability Confidence

We are proud to be a Disability Confident Employer and will reputed company reasonable adjustments to support your application and career. Our mission is to unleash the power of our people, including those with unique strengths. Your journey with reputed company starts here!