Overview
Remote
On Site
Hybrid
$55 - $60 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)
Skills
CLINICAL DATA
DATA MANAGEMENT
ICH
E6
TRANSFORMATION
TRANSFORMATIONAL
TRANSFORM
TRANSFORMED
TRANSFORMING
ELECTRONIC DATA CAPTURE
EDC
MEDIDATA
VEEVA
TABLEAU
POWER BI
POWERBI
VISUALIZATION
Job Details
Payrate: $55.00 - $60.00/hr.
Summary:
To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.
Responsibilities:
Qualifications:
Desired Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $55.00 - $60.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
# 25-20539
Summary:
To provide expertise in data management processes, demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.
Responsibilities:
- Develop Data Management playbook to encompass new ways of working with key accountabilities defined and known, both internally within function as well as broader study team
- Assess and determine roles and responsibilities within the Data Management Team
- Cleansheet Data Management processes and identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs.
- Collaborate with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.
- Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally - consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an appropriate risk-based approach, eg. reduced SDV etc
- Develop and document standard operating procedures (SOPs) for data management activities
- Analyze existing workflows and identify bottlenecks with new ways of working
- Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.
- Determine key performance indicators (KPIs) and suggest data-driven improvements
- Delivering a quality, fit for purpose dataset - plan, build, review with the end in mind (protocol - data collection - data review - analysis - archive)
- Evaluate new data management tools and technologies (e.g., EDC systems, data integration platforms, data flow).
- Participate in system design, and user acceptance testing.
- Role model with staff on new technologies and ensure smooth integration into new and/or modified processes
- Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-Google Cloud Platform).
- Collaborate with clinical teams to ensure data collection aligns with study objectives.
- Serve as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.
Qualifications:
- Doctorate degree and 2 years of experience, or Master s degree and 4 years of experience or Bachelor s degree and 6 years of experience or Associate s degree and 10 years of experience, or High school diploma / GED and 12 years of experience
- Deep knowledge of clinical data management processes and systems (e.g., EDC, CDISC standards, External Data Collection, eg eCOA, Central Labs etc).
- Familiarity with data visualization tools and data analysis techniques.
- Minimum of 10 years of experience in clinical data management or related field.
- Proven track record of leading delivering on complex process improvement initiatives
- Ideally proven track record of delivering on complex technology implementations.
- Familiarity with Electronic Data Capture (EDC) systems (e.g., Veeva, Medidata).
- Knowledge of data visualization tools (e.g., Tableau, Power BI).
- Knowledge in statistical software (e.g., SAS, R) for data analysis.
- Knowledge, and ideally experience, of working with risk-based approaches (e.g. delivering studies using reduced SDV etc)
Desired Skills:
- Strong problem-solving skills with the ability to analyze complex data sets.
- Ability to interpret regulatory requirements and translate them into actionable processes.
- Experience in managing projects, ensuring timely delivery and adherence to budgets.
- Skills in change management to effectively implement new processes and technologies.
- Experience with managing projects involving staff transitions between vendors
- Excellent verbal and written communication skills for effective collaboration.
- Ability to present complex data and concepts to diverse audiences.
- Risk Based Quality Management Experience
- ICH E6 knowledge
- At least 10 years Mgt experience - need a Data Management background.
- Knowledge of working with Data Mgt teams in a remote environment.
- Veeva Knowledge is preferred
Pay Transparency: The typical base pay for this role across the U.S. is: $55.00 - $60.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
# 25-20539
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.