Manager – Clinical Research & Analytics
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body to transform the treatment of cancer, autoimmune and inflammatory diseases. Cue Biopharma is a high growth company and is listed on Nasdaq: (CUE). The company is located in Boston, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists and clinical personnel to help us advance our research and clinical development programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
This is a full-time position reporting to the Senior Director, Clinical Research & Biometrics. The successful candidate will work closely with the Senior Director to establish and implement in-house processes to review, assess and report emerging clinical trial data throughout the data lifecycle. Real-time data is used for safety surveillance, trend identification, metric reports, presentations to senior management and external stakeholders, as well as submissions to regulatory agencies and business partners. The successful candidate will participate in cross functional teams with the Chief Medical Officer and Senior Medical Director, as well as the Clinical Operations, Quality Assurance and Translational Medicine teams. The successful candidate will work at the company office (Boston, MA) however consideration will be made for an experienced candidate to work remotely. This position does not involve any on-site monitoring activity or significant travel.
- Developing tools and processes to increase accuracy and integrity of clinical trial data.
- Ongoing real-time review of clinical trial data for accuracy, issues, trends.
- Creating and managing master clinical data trackers in real-time.
- Creating and updating plots and figures in real-time (spider plots, swimmer plots, waterfall plots, etc.).
- Creating and maintaining in-house clinical data review and query logs.
- Preparing reports for internal discussion/presentation (metrics, data summaries, snapshots of efficacy/safety findings, etc.).
- Collaborating with CROs in all data aspects of clinical trials.
- Participating in development of database specifications and data validation checks/edit checks for EDC.
- Participating in UAT of clinical databases and data validation checks.
- Reviewing adequacy and accuracy of TLFs with the SAP and protocol.
- Participating in activities related to CSR, DSUR, integrated safety reports, manuscripts, abstracts, posters, scientific meetings, and data aggregation across studies.
- Ensuring that regulatory requirements are met through validation/compliance activities.
- University degree in a health or science-related field.
- Minimum 7 years of experience in the pharmaceutical/biotech/CRO setting as a Clinical Research Associate, Clinical Project Manager, Clinical Data Analyst, Clinical Data Reviewer or similar.
- Knowledge of fundamental research principles relating to data collection and management.
- Experience in oncology/immunotherapy trials with experience using Rave, Inform and IBM EDC systems.
- Current GCP training.
- Demonstrated knowledge of research regulations and guidelines, such as ICH/GCP, Tri-Council Policy, FDA CFR.
- Proficiency with MS Office software (Outlook, Word, Excel, PowerPoint). Experience in Excel pivot tables and Prism an asset.
- Organizational and time management skills with the ability to quickly adjust to changing priorities.
- Initiative-taking; ability to work well independently as well as part of a team.
- Strong analytical & critical thinking skills.
- Strong verbal and written communication skills, with excellent listening skills.
- Fluent in English (written and verbal).
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