Clinical Data Manager, Digital Medicine and Translational Imaging - FSP - East Coast US

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: We are looking for a self-directed professional to support clinical data management efforts for the biomeasures endpoints projects. This individual will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. They will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas. In close partnership with colleagues from Research teams from Research and Development, They will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.

Requirements

Master's degree in Health Informatics, Computer Science, Information Systems, or similar field required
A minimum of 5+ years of technical experience required, including:
Python
Unix/Linux environments
Version control systems (ex. Git)
AWS or other cloud-based development
Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
GCP experience
Strong interpersonal and collaboration skills
Demonstrate the ability to build consensus and be agile to changing circumstances and priorities
Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements

Responsibilities

Data Management POC for studies in which we are included in
Responsible for mapping local study dictionaries to CDISC Standards
Participate and contribute to the development of operational plans to ensure data quality and completeness
Develop, Implement, and Conduct data quality checks as needed for work/studies
Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains
Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics
As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11
Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
Manage own time to meet agreed targets
Work under general supervision. Performs assignments using established procedures and general instruction
Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.