Duke University Job Descriptions

CLINICAL DATA MANAGER, SR.

Job Title: CLINICAL DATA MANAGER, SR.
Job Code: 1335
FLSA: E
Job Level: 53
Revised Date: 01/08/2024
Job Family: JF 05

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Occupational Summary

Leads day to day operations of multiple study teams managing clinical research data at Duke Health; performs a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; lead others in navigating the clinical research environment. Collaborates with other data-focused Departmental and Institutional groups. Oversees the work of clinical research data and other research staff.

Work Performed

Research Operations

Serves as an expert resource to multiple study teams about regulatory, institutional policies and processes, and study level documentation.

Maintains study-level documentation (e.g., involving datasets from multiple sources, big data, or non-standardized data) for all studies, including those that are complex in nature (e.g., procedural and interventional studies).

Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams.

For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution.

Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Safety and Ethics

Provides oversight and training to multiple study teams who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data

Under direct supervision from Biostatistician and PI may perform basic analyses on a variety of data formats. May provide mentorship or education to others on programs and tools for data cleaning and analysis.

For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol. Provides training and oversight into EDC creation using appropriate data standards.

Oversees the process of QA, data corrections, and queries used by multiple study teams, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain study teams. Serves as a data corrections, queries, and quality assurance expert resource within CRU, department, or division; including liaising with and being knowledgeable about other related resources at Duke.

Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and provenance. For studies reporting to the FDA, coordinates the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks.

Oversees the process of depositing data in repositories. Provides guidance on the selection of the appropriate repository and any data governance requirements.

Performs de-identification on allowable data to Safe Harbor standards, or on consented data leaving Duke under agreements. Could serve as a Federated Honest Broker. May provide training to others.

Serves as an expert resource to multiple study teams with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams work through solutions.

Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams, as relevant.

Develops, oversees adherence, and trains to multiple study teams on the results reporting for patients and providers. Provides guidance based on CRU and institutional best practices.

Awareness of appropriate methods for monitoring study progress based on trial design. Uses benchmarks where appropriate to compare to similar studies, networks, or goals and tracks progress and compliance.

Recognizes when 21 CFR Part 11 applies to a project and follow policy related to testing and validation. Provides oversight and training to multiple study teams on validation and testing for EDCs.

Scientific Concepts

Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals.

Provides guidance around FAIR data and open science implementation.

Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.

Uses expertise in research design to provide significant contribution to protocols or research proposals.

Provides significant contribution or leadership on accepted, peer- reviewed publications or conference presentations. Mentor others in this area.

Site and Study Management

Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits and the implementation of operational plans across multiple study teams or sites.

For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies and develops and implements closeout procedures.

Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership and professionalism

Encourages and provides opportunities for staff to take part in professional development and to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).

Demonstrates interpersonal skills to get work done efficiently. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Recognizes and escalates organizational issues that could be optimized to improve research process.

Actively facilitates and leads multiple study teams adoption of change in their working environment. Plays key role on committees and workgroups. Trains other to communicate effectively within teams.

Facilitates resolution of issues associated with teams or communication.

Required Qualifications at this Level

Education/Training

Completion of an Associate's degree

Experience

Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience.

Skills

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

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The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

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Essential Physical Job Functions

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.