Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Manager to join their expanding team.
Find out more about this role by reading the information below, then apply to be considered.
Position Details:
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:
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 and Pharmaceutical.
Position Responsibilities
Operational and vendor engagement POC for BEST and Clinical studies in which we are included
Contributes to overseeing and monitoring DHT-derived and/or imaging data into Pharmaceutical
Tracks emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
Develops 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
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
Contributes to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
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 BEST, Digital Quantitative Sciences, Clinical Data Sciences, Data Acquisition, Biostatistics, Development Operations and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered studies.
Technical Skills Requirements
Basic Qualifications
BA/BS degree in Health Informatics, Computer Science, Information Systems, or similar field
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
At least three 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
Masters 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
Physical/Mental Requirements
Ability to perform mathematical calculations and ability to work with large complex data sets.
Physical Position Requirements
Office work
Comments:
Candidates MUST currently be local to Cambridge site
Minimum Education:
A minimum of a BA/BS in Health Informatics, Computer Science, Information Systems, or other similar scientific field
At least three years of experience, including:
Research/clinical trial experience
Electronic data captures (EDC) solutions, e.g., REDCap, Oracle Clinical
Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
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
GCP