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Parexel · 2 days ago

Data Management Lead

United States

Full-time

Remote

Senior Level

7+ years exp

Parexel is dedicated to advancing clinical research and supporting medical affairs with innovative solutions. They are seeking a dynamic and experienced Data Management Lead to oversee trial data activities and ensure high-quality data management in oncology. The role involves developing risk management strategies, engaging with stakeholders, and managing cross-functional data management leadership.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects

Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones

Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models

Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data

Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results

Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis

Manage and coordinate the integration and utilization of all ancillary systems

Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan

Review and analyze metrics to derive meaningful summaries of study health and trends

Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators

Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs

Ensure appropriate project-level resourcing of staff and staff assignments

Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand

Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope

Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole

Support other functions by providing meaningful feedback on initiatives

Ensure Parexel-requested information entered into management systems is accurate and regularly updated

Maintain training compliance as per job roles assigned, including on-the-job training

Deliver project-specific training to internal Data Management teams

Address training needs based on identified development goals

Qualification

Clinical data managementCDISC data standardsData analytics toolsProject managementMedical affairs experienceProgramming languagesLeadership skillsFluency in EnglishCollaboration skillsCommunication skills

Required

BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience

7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)

Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology

Strong project management experience

Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required)

Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity

Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing

Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques

Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment

Ownership and accountability relative to key accountabilities in the job description

Ability to travel as required

Written and oral fluency in English

Preferred

Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI)

Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau)

Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming

BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)