Title: Associate Director Data Operations

Location: Cambridge - MA

Duration: 12 Months’

Pay Rate: $76/hr

POSITION 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 Client 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 Client.

Skills

• 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:

o Research/clinical trial experience

o Electronic data captures (EDC) solutions, e.g., REDCap, Oracle Clinical

o Familiarity with pharmaceutical informatics standards like CDISC and MedDRA

o 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

o GCP

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 Client

• 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 Client stakeholders to understand evolving project portfolio needs, and integration into the Client 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:

o Python

o Unix/Linux environments

o AWS or other cloud-based development

o Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave

o 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.

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