Job Description

job summary:
We are looking for a self-directed medical informatics professional to support clinical data management efforts for Digital Science & Translational Imaging (DSTI) projects and the Innovation Research (PfIRe) Lab. This person 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. S/he will act independently as a data manager on study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.

In close partnership with colleagues from WRDM Research Units and asset teams from Global Product Development (GPD), you 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. You will need to communicate effectively with the DMTI Leadership Team (DMTI LT) and interact effectively with colleagues within a matrix organization to help conduct key studies to drive portfolio decisions. 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 and company.

location: Cambridge, Massachusetts
job type: Contract
salary: $56.34 - 73.94 per hour
work hours: 9 to 5
education: Masters

responsibilities:
- Data Management POC for DSTI and Clinical studies in which we are included in

- Responsible for mapping local study dictionaries to CDISC and company standards

- Participates and contributes to the development of Clinical Outcome Assessments (COAs) for Electronic Data Capture

- Develops, Implements and Conduct data quality checks as needed for work/studies

- Works closely with the various stakeholders to understand evolving project portfolio needs, and integration into the company systems and requirements; supporting studies with a wide range of disease domains.

- Contributes 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 PfIRe lab, asset teams, and external collaboration studies is consistent with 21CFR part 11.

- Contributes to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements.

- Tracks emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality

- Manages own time to meet agreed targets

- Works under general supervision. Performs assignments using established procedures and general instruction.

- Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.

qualifications:
BASIC QUALIFICATIONS:

- Master\'s degree in Health Informatics, Computer Science, or Information Systems

- At least five years of technical experience, 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

- Strong interpersonal and leadership skills

- Demonstrate the ability to build consensus and drive change across the organization

- Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements

PREFERRED QUALIFICATIONS:

- Clinical trial experience

- Experience with electronic data captures (EDC) solutions, e.g., REDCap, Medrio

- Familiarity with medical informatics standards like CDISC

- Experience with AWS or other cloud-based development

- Experience processing large data sets (including from digital health technologies) in a distributed computing environment

- Experience with SQL or NoSQL-based technologies

- Comprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing tools

skills: Data Analysis, CDISC, CRFs, Clinical Data Management, EDC (Electronic Data Capture), MedDRA

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate\'s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Randstad