associate director data operations - first shift.
cambridge , massachusetts
posted today
job detailssummary
$56.47 - $74.99 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference49069
job detailsjob 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 novel digital and imaging endpoints across different therapeutic areas.In close partnership with colleagues from Research teams from Research and Development (PRD), you will play a key role in the deployment of novel 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 company.location: Cambridge, Massachusettsjob type: Contractsalary: $56.47 - 74.99 per hourwork hours: 8 to 4education: Bachelorsresponsibilities:
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 company
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 stakeholders to understand evolving project portfolio needs, and integration into the 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 RELATIONSHIPSPartners 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.qualifications: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:
o Pythono Unix/Linux environmentso AWS or other cloud-based developmento Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Raveo 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 REQUIREMENTSAbility to perform mathematical calculations and ability to work with large complex data sets.skills: CDISC, Data Validation Plan, Clinical Data Management, GCP (Good Clinical Practice), EDC (Electronic Data Capture)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).This posting is open for thirty (30) days.