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Clinical-Scientific - Clinical Data Manager - Groton, United States - Pioneer Data Systems
Description
Position Details:
Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Analyst to join their expanding team.
Job Title:
Clinical Data Analyst / Pharma Industry
Duration: 24 months contract, extendable up to 36 months
Location:
Cambridge, MA
Note:
The client has the
right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group
medical insurance plan
Job Description:
Position Summary
We are looking for a self-directed professional to support clinical data management efforts for the Biomeasures Endpoints and Study Technologies (BEST) projects and the Pharmaceutical Innovation Research 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 and define ways to improve operational processes for these activities.
S/he will act independently and in collaboration with study teams seeking to develop and validate Client digital endpoints across different therapeutic areas.
In close partnership with colleagues from Research teams from Pharmaceutical Research and Development (PRD), you will play a key role in the deployment of Client digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers.
You will need to communicate 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 Pharmaceutical.
Position Responsibilities
Data Management POC for BEST and Clinical studies in which we are included in
Responsible for mapping local study dictionaries to CDISC and Pharmaceutical Standards
Participates and contributes to the development of operational plans to ensure data quality and completeness
Develops, Implements and Conduct data quality checks as needed for work/studies
Works closely with the various Pharmaceutical stakeholders to understand evolving project portfolio needs, and integration into the Pharmaceutical 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 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.
Organizational Relationships
Partners with colleagues in Lab, Biostatistics, Development Operations, Regulatory, Data Standards and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered studies.
Education And Experience
Master's degree in Health Informatics, Computer Science, Information Systems, or similar field
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
GCP
Technical Skills Requirements
Basic Qualifications
Master's degree in Health Informatics, Computer Science, Information Systems, or similar field
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
GCP
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
Preferred Qualifications
Clinical trial experience using and deploying digital health technologies
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
Physical/Mental Requirements
Ability to perform mathematical calculations and ability to perform complex data analysis.
Location:
100% ONSITE in Cambridge
