Clinical Data Engagement Manager

Prolaio•Chicago, IL

5d•$130,000

About The Position

The Clinical Data Engagement Manager will serve as the primary interface between Prolaio's Data team and its clinical research sponsor partners. This role is responsible for owning the end-to-end sponsor data relationship: from requirements gathering and Data Transfer Agreement (DTA) management to data deliverable oversight and quality control. The Clinical Data Engagement Manager will translate sponsor needs into structured internal project briefs, drive delivery execution, collaborate closely with Prolaio's internal teams to ensure alignment across data and operational workstreams, and serve as a trusted, knowledgeable point of contact for sponsor Biostatistics and Clinical Operations teams throughout the lifecycle of each study. Data quality review is a core responsibility of this role; this role is accountable for identifying and surfacing quality issues before they reach the sponsor.

Requirements

BS/MS in Life Sciences, Clinical Research, Public Health, Biostatistics, or a related field.
5+ years of experience in clinical research, clinical data management, or a sponsor/CRO-facing role within the pharmaceutical, biotech, or medical device industry.
Demonstrated understanding of clinical trial structure, data flows, and the roles of Biostatistics and Clinical Operations within a study team.
Experience managing or supporting client-facing deliverables in a regulated clinical research environment, including data quality review and communication of findings.
Strong written and verbal communication skills, with a proven ability to translate complex data concepts for non-technical clinical stakeholders.
Exceptional organizational skills and attention to detail, with demonstrated ability to manage multiple concurrent studies and deliverable timelines.

Nice To Haves

Familiarity with decentralized clinical trial (DCT) methodologies, wearable devices, or digital biomarker data (training can be provided).
Experience with Data Transfer Agreements or data governance documentation in a clinical or regulated setting.
Exposure to data analytics tools or platforms (e.g., SQL, cloud-based data warehouses, clinical dashboards) sufficient to engage technically with data team outputs.
Experience working with or alongside biostatisticians, including familiarity with statistical analysis plans (SAPs) or data deliverable specifications.
Experience in cardiology, cardiovascular research, or related therapeutic areas is a plus.
Comfort operating in a fast-moving, early-stage company environment where the role will evolve as the Data Services function scales.

Responsibilities

Serve as the primary point of contact for sponsor Biostatistics and Clinical Operations teams across all active studies, managing data-related communications, expectations, and escalations.
Own the planning, coordination, and quality control of all monthly data deliverables, ensuring outputs meet agreed specifications, timelines, and quality standards prior to client delivery. This includes reviewing deliverables for data quality issues and driving internal resolution before sponsor submission.
Manage and maintain all Data Transfer Agreements (DTAs), ensuring terms are current, accurately reflect study scope, and are updated in alignment with protocol or data requirement changes.
Translate sponsor data requirements into structured internal project briefs, clearly documenting sponsor needs, success criteria, and acceptance conditions to guide Data Services execution.
Collaborate with internal teams, such as Data Science, Tech, and Operations, to align data and operational workstreams, ensuring a seamless and consistent sponsor experience across all client-facing functions.
Lead sponsor-facing data onboarding for new studies, establishing data exchange workflows, communication cadences, and delivery expectations from study initiation through closeout.
Proactively identify and surface data-related risks or sponsor concerns to Data Services leadership, providing context and recommended resolutions to support timely decision-making.
Maintain thorough documentation of sponsor requirements, data agreements, delivery logs, and open action items to ensure continuity and institutional knowledge retention.
Track and report on data delivery KPIs across active studies, ensuring accountability to agreed timelines and quality metrics and escalating deviations proactively.