Client Data Management Specialist at Adaptive… · Remote…

Position Overview

The Client Data Management Specialist plays an important role within the Client Data Management (CDM) team and contributes to maximizing Adaptive’s revenue through generation and delivery of clinical trial data for high-value BioPharma customers using Adaptive’s MRD assays.

The position works closely with internal stakeholders and BioPharma customers to establish study-specific Data Transfer Agreements (DTAs) and to generate data of the highest quality as per the specifications of those documents, while meeting internal and external deadlines, keeping study documentation and data delivery methods up to date, and performing data updates.

The position is also responsible for assisting in the design, development, review and maintenance of software code to generate study-specific customer data files and data analysis tools, and/or to provide project management support to the CDM team.

This role requires impeccable attention to detail, great communication skills, the ability to collaborate with internal and external stakeholders to establish data-related study requirements and troubleshoot issues, a good command of Adaptive’s systems and processes, knowledge of molecular biology and/or high throughput analysis, and the ability to adapt to evolving priorities in a rapidly evolving landscape.

Key Responsibilities and Essential Functions

Deliverable Generation

• With assistance from the broader team as needed, collects study data and generates, reviews and delivers study files to customers as per study specifications, using multiple internal and external resources as needed in consultation with other CDM team members to deliver data timely and achieve the goals of Adaptive and clients.
• Supports cross-functional efforts to troubleshoot issues and to ensure study deliverables can be generated in an efficient and timely manner. Cross functional partners include Business Development (BD), Alliance Managers (AMs), Client Managers (CMs), Analytical Project Managers (APMs), and the Sample Management, Software and Computational Biology teams.
• In consultation with other team members, reviews customer data queries, and implements and verifies data cleanup activities as needed for reconciliation needs.
• Supports discussions with Clinical Operations, Regulatory Affairs, and Commercial teams to align data workflows.
• Awareness of client data architecture and lifecycle management needs.

DTA Management

• Serves as main point of contact for DTA-related discussions for assigned customers, including projects of low to medium complexity and scope.
• Participates in training and assists with DTA implementations.
• Monitors and maintains DTAs for assigned customers.
• Drafts and reviews low-complexity DTAs that meet data needs for new and existing customers, participating in negotiations with customers, and finalizing them under supervision.
• Develops an understanding and awareness of general customer data needs.
• Alerts the CDM team of any conformity issues related to custom clinical database specifications and solves them in collaboration with other team members.
• Uses analytical insights to suggest process improvements and ensures conformity with custom clinical database specifications.

Client Communication

• Attends meetings with assigned customers (low to medium complexity and scope) and third-party data managers during study set up and implementation to support customer data needs with team support. Keeps detailed notes for CDM’s future reference.
• Responds to client needs and ad-hoc inquiries using company-wide systems such as SalesForce, TaskRay, Tableau, Gitlab, JIRA and the data warehouse with support from other team members.
• Suggests process improvements and trains on best practices to systematically address client questions and inquiries.
• Responds to client questions using general understanding of data and biological sciences
• Coordinates communication regarding user access for internal and external platforms.
• Assists in interactions with data-end users and the data storage/management architecture team to ensure that systems meet business and client needs.

Software Tool Generation & Validation (Coding & Scripting)

• Under supervision, runs, creates, and maintains JSON scripts to process, clean, and generate study-specific deliverables for Biopharma study sponsors. Researches and applies solutions to scripting tasks (i.e. Python Documentation)
• Under supervision, creates, implements, and maintains new and existing scripts and enhancements to meet sponsor specific reporting requirements.
• Participates in team efforts to solve low to moderately complex data wrangling efforts.
• Follows established processes for the maintenance of the code repository for data analysis tools. Under supervision, supports the development of new data analysis tools following conventional coding practices to accommodate CDM and BioPharma team needs.
• Utilizes the established tools and processes to ensure quality data collection accuracy and upkeep.
• Assists external user set up and access to data management systems.
• Assists in the development of custom tools to improve and automate existing processes, streamline data workflows, and enable scalable business operations.
• Ensures documentation and compliance by maintaining version control through GitLab, reviewing standard operating procedures (SOPs) for data/sample management, and monitor compliance with data security protocols.

Order Tracking & Management

• Assists in monitoring orders, aligning with cross-functional teams and assigning data release related activities to other team members to ensure data management deliverables are met on time under supervision from team lead.
• Assists with CDM reporting and analytics efforts to support leadership decision-making.
• Utilizes communication skills, available metrics and reports, experience, knowledge, and other resources to coordinate data management activities including order and revenue tracking and forecasting.
• Participates in discussions with study team members from different functional areas to ensure they deliver components affecting data to ensure successful and timely execution of deliverables.
• May lead CDM weekly calls to coordinate with the team on project deadlines and DTA statuses.

Other

• May evaluate existing CDM processes and recommend improvements to streamline data workflows and data delivery to remove inefficiencies and enable the continuous growth of the business. Works with more senior team members to implement improvements.
• Performs regulatory responsibilities per Good Manufacturing Practices (GMP).
• Participates in the management and maintenance of CDM documents (including SOPs, training and guiding documents) and ensures tracking systems are kept up to date.
• All other duties as assigned.

Position Requirements (Education, Experience, Other)

Required Education

• Bachelors + 2 years of related experience, or
• Masters + 0 years of related experience

Required Technical Skills

• Database Management: Exposure to database management best practices.
• Data Tools: Exposure to data tools and programming languages such as Java, Python, or R as well as software tools (such as excel, bash, and git).
• Analytics & Reporting: Skills in data analysis, identifying trends, and developing solutions through data analysis.

Required Competencies

• Analytical & Problem-Solving: The ability to analyze complex data, identify patterns, and develop effective solutions.
• Communication: Excellent written and verbal communication skills are needed to interpret and share insights with both technical and non-technical teams.
• Organizational: A high level of organization is required to manage incoming data files, maintain data systems, and ensure data accuracy.
• Attention to Detail: A strong focus on detail is essential to ensure the accuracy and integrity of sensitive client information.
• Teamwork: Ability to work as part of a team effectively and efficiently in a quick turnaround environment with tight deadlines.

Preferred

• Data Governance: Understanding of data governance, security, and compliance standards.
• Client Engagement: Client-focused skills, including empathy and the ability to engage and communicate effectively with clients.
• Regulatory Compliance: Knowledge of data protection regulations, such as GDPR.
• Clinical Trials: Knowledge of clinical trials process including phases, key timelines, regulatory oversight, and key processes such as IRB Approval, FDA Submission, FDA approval, GCP guidance, and data analysis
• AI/Automation tools: Exposure to AI-driven insights to support data interpretation and coding/scripting, quality control, and refining client correspondence.
• Knowledge of molecular biology and/or high throughput data analysis, or related fields.
• Knowledge of project management principles

#LI-Remote

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Compensation

Hourly Rate: $34.33 - $51.53

Possible “other compensation” elements to include:

• equity grant
• bonus eligible