Job Title: Clinical Data Manager/ Data Operations Manager

Location: Cambridge, MA 06340

Duration: 24 Months contract

Payrate: $50- $56/hr on w2 without benefits

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 Client Innovation Research (PfIRe) 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 Client 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 client.

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 client 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 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.

• As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from PfIRe 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 PfIRe 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:

o Python

o Unix/Linux environments

o Version control systems (ex. Git)

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

o 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:

o Python

o Unix/Linux environments

o Version control systems (ex. Git)

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

o 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