Associate Director
1 week ago
Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Manager to join their expanding team.
Job Title: Clinical Data Manager / Digital Health Technology
Duration: 12 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:
Summary:
We are looking for a self-directed professional to support Digital Health Technology [DHT] (wearable sensors) and imaging components set-up and monitoring within clinical trials; specifically focused on the operational initiation/set-up, vendor and digital data/imaging monitoring, and data cleaning process efforts that occur within the Biomeasures Endpoints and Study Technologies (BEST) projects.
This person will be responsible for assisting in setting up, working with vendors, monitoring and reviewing patient DHT-derived digital and/or imaging data, imaging and digital data preparation activities as well as define ways to improve operational processes for these activities.
S/he will act in collaboration with BEST study teams, and partners, seeking to develop and validate Client digital and imaging 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 and imaging measures 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 decision making.
This role will be central to the deployment and scaling of digital and imaging solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.
Responsibilities:
Operational and vendor engagement POC for BEST and Clinical studies in which we are included
Contribute to overseeing and monitoring DHT-derived and/or imaging data into Pharmaceutical
Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
Develop 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 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
Contribute technical expertise toward the design, implementation and scaling up of sensor systems and analytics
Ensure collection, organization, curation, storage and safeguarding of patient data from BEST teams, 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
Manage own time to meet agreed targets
Work under general supervision
Perform assignments using established procedures and general instruction
Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications
Minimum Qualifications:
BA/BS degree in Health Informatics, Computer Science, Information Systems, or similar field
Experience with digital vendor management and operational monitoring of digitally derived data
Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data extraction, and IRB/regulatory requirements
A minimum of 3+ years of technical experience, including:
Python
Unix/Linux environments
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 collaboration skills
Demonstrate the ability to build consensus and be agile to changing circumstances and priorities
Preferred Qualifications:
Master's degree in health informatics, computer science, information systems or a similar scientific field
Clinical trial experience involving, operationalizing, deploying and monitoring digital health technologies and imaging associated data
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
Location:
This is a fully onsite role in Cambridge, MA; candidates must be local to the area
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