Job Title: Data Management Sr Mgr
Location: Remote
Duration: 1 year

Top 3 Must Have Skills:

• Transformational Knowledge – large projects with changes (Pharma Background)
• 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.

Job Purpose: 

• 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.

 Day to Day Responsibilities:

• This role will drive critical milestones across process redesign, technology implementation, and new ways of working.
• The ideal candidate will bring deep domain expertise in clinical data management and systems, and will work closely with senior leaders across the organization to shape and deliver the future operating model.
• Work directly with senior leaders and transformation workstream owners across all functions in development operations, clinical systems, statistics, quality, and broader development and IT ecosystem.
• Serve as a trusted SME and connector across functional groups to ensure alignment, accountability, and clear decision-making
• Actively contribute to cross-functional design sessions, workshops, and leadership updates related to the transformation

Job Description:
Clinical Trial Delivery Operating Model:

• 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

Process Improvement:

• 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)

New Technology Design and Implementation:

• 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

Regulatory Compliance and Quality Assurance:

• Ensure all data management activities comply with regulatory standards (e.g., FDA, EMA, ICH-GCP)

Cross-Functional Collaboration:

• 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.

Core Competencies:

• Technical Expertise: 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.
• Analytical Skills: Strong problem-solving skills with the ability to analyze complex data sets. Ability to interpret regulatory requirements and translate them into actionable processes.
• Project Management: 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
• Communication Skills: Excellent verbal and written communication skills for effective collaboration. Ability to present complex data and concepts to diverse audiences.

Experience & Knowledge:

• 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)

Basic 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

Possible Extension: Yes
Red Flags: NA
Interview Process: Video Conference 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/hr.