Clinical Data Analyst / Digital Health Technology / Pharma Industry

Our client, a world-leading Pharmaceutical Company in Cambridge, MA is currently looking for a Clinical Data Analyst to join their expanding team.

Position Details : Job Title : Clinical Data Analyst / Digital Health Technology / Pharma IndustryDuration : 12 months contract, extendable up to 36 monthsLocation : Cambridge, MANote : 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 planJob 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 includedContributes to overseeing and monitoring DHT-derived and / or imaging data into PharmaceuticalTracks emerging study data and works closely with data science team to ensure the effectiveness of tools and data qualityDevelops and contributes to the development of operational plans to ensure data quality and completenessDevelops, Implements and Conduct data quality checks as needed for work / studiesWorks 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 domainsContributes technical expertise toward the design, implementation and scaling up of sensor systems and analyticsEnsure collection, organization, curation, storage and safeguarding of patient data from BEST teams, asset teams, and external collaboration studies is consistent with 21CFR part 11Contributes to the overall architecture of the existing data pipelines and workflows, recommends and implements improvementsManages own time to meet agreed targetsWorks under general supervisionPerforms assignments using established procedures and general instructionShares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publicationsOrganizational 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 fieldDigital vendor management and operational monitoring of digitally derived dataHands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB / regulatory requirementsAt least three years of technical experience, including : PythonUnix / Linux environmentsAWS or other cloud-based developmentElectronic data captures (EDC) solutions, e.

g., REDCap, Encapsia, Oracle Clinical, Medidata RaveFamiliarity with pharmaceutical informatics standards like CDISC and MedDRAStrong interpersonal and collaboration skillsDemonstrate the ability to build consensus and be agile to changing circumstances and prioritiesPreferred Qualifications : Masters degree in health informatics, computer science, information systems or a similar scientific fieldClinical trial experience involving, operationalizing, deploying and monitoring digital health technologies and imaging associated dataExperience processing large data sets (including from digital health technologies) in a distributed computing environmentExperience with SQL or NoSQL-based technologiesComprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing toolsPhysical / Mental Requirements : Ability to perform mathematical calculations and ability to work with large complex data sets.

Work Schedule : Monday - Friday - dayshiftInterview : preferably onsite - Panel with team.Minimum Education : A minimum of a BA / BS in Health Informatics, Computer Science, Information Systems, or other similar scientific fieldAt least three years of experience, including : Research / clinical trial experienceElectronic data captures (EDC) solutions, e.

g., REDCap, Oracle ClinicalFamiliarity with pharmaceutical informatics standards like CDISC and MedDRAHands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB / regulatory requirementsGCP