Harbinger : Clinical Data Manager

Clinical Data Manager

Harbinger Health, a Flagship-founded company, is pioneering early cancer detection. Harbinger aims to detect cancer, at the earliest stages, to save lives. Our platform leverages proprietary biological insights and artificial intelligence to enable high-resolution, molecular views on cancer from blood. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

Position Summary

The Clinical Data Manager will execute the data management activities for Harbinger Oncology’s clinical studies and other clinical efforts. This position is responsible for ensuring the accurate, complete, and timely collection, management, and delivery of assay/genomic and clinical data for analysis, reporting, and presentation.

Responsibilities:

• Work closely with the study team and strategic partners to ensure that clinical data captured is complete, consistent, and accurate. 
• Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and EDC set-up.
• Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies.
• Utilize programming skills and appropriate tools to provide information as required by study team members.
• Provide data visualizations for clinical trial metrics.
• Lead data locking efforts, ensuring that study team members have executed according to the CDMP toward the goal of achieving analysis-ready datasets.
• Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data, and bio-specimen data. 
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Develop dashboards for monitoring clinical trial enrollment and other metrics
• Work with the digital team to assure pipelines for clinical data ingestion is seamless with high fidelity
• Effectively communicate findings to stakeholders

Qualifications:

• Bachelors degree required; advanced degree preferred. Additional coursework in programming, analytics, or related fields strongly desired.
• 5+ years of industry experience required, with a strong track record of EDC system implementation and collaboration with study teams to ensure data quality.
• Knowledge of clinical trials and medical device and/or drug development processes. Experience working on study start up, database locks, analysis timepoints and study closeout. 
• Experience working on studies under the purview of the FDA and MHRA is a plus. 
• Familiarity with various data visualization, analytics, and reporting tools.
• Scientific programming, database, and dashboards development experience; Ability to work hands on with data using spreadsheet software required. 
• 2+ years experience programming in Python and SQL preferred, but will accept R or SAS as well.
• Strong experience with multiple EDC systems (Medrio, RedCapCloud, or similar)
• Experience implementing EDC systems
• Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings
• Knowledge of GCP, ICH Guidelines, HIPPA, GDPR and use of good clinical data management practices
• Molecular diagnostics industry experience preferred.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex,