Manager, Clinical Informatics - Cambridge, MA | Biospace
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Manager, Clinical Informatics

Jounce Therapeutics

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Location:
Cambridge, MA
Posted Date:
5/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Manager of Clinical Informatics will be responsible for the clinical data infrastructure and related IT services supporting the Development organization and Clinical Trials at Jounce. This is a key role supporting the information systems and processes involved in the collection, review, archival, retrieval and analysis of clinical data. This individual will be the first Informatics resource dedicated to Clinical Development and will be instrumental in building and shaping the future Clinical Informatics environment and infrastructure. The role will be working in a fast paced biotech environment. This position reports to the Sr. Director of Informatics and Operations.

Responsibilities:



Collaborate with the Sr. Director of Informatics and Operations and the Development Organization to architect a strategy and roadmap for Jounce Clinical Informatics
Work closely with the Development staff and Clinical Study Teams to
Assess relevant clinical business processes and identify gaps
Provide recommendations for systematic improvements in terms of information sharing and collaboration
Select and implement information systems for managing clinical samples and clinical data including Clinical LIMS, Clinical Data Warehouse and other projects as part of the aforementioned roadmap
Work closely with Clinical Ops team, Stats team, Subject Matter Experts within functional groups, and CROs to support data transfers to and from Jounce
Collaborate with QA and Jounce IT to ensure compliance with validated information systems required
Build self-service data visualization and query tools for Development team
Provide support for Development programs in collaboration with CROs and Jounce IT
Provide training on Clinical Informatics solutions to Jounce staff

Requirements

Bachelor’s degree or higher in Science or related field
8+ years working in Biotech / Pharmaceutical industry related to Clinical Information Systems, Drug Development, and/or Clinical Trials
Experience with Clinical Sample Management, Clinical LIMS
SAS System administration and experience supporting a Biostatistics team
Experience selecting and implementing vendor provided Clinical Information Systems
Working knowledge of 21 CFR part 11 and experience with software validation in the pharmaceutical industry preferred
Experience supporting Quality Assurance and associated IT systems (e.g. QMS)
Strong communication and interpersonal skills
Ability to work effectively on cross-functional teams
Strong business analysis and process definition skills
Data Warehousing, Data Modeling skills are a plus
Experience integrating multiple information systems using SQL, ETLs, web services, or other technologies preferred
Familiarity with Data Visualization tools (e.g. Spotfire, Tableau) preferred