Full-Time
Data Management Lead (Medical Affairs) - Oncology
Posted on 12/13/2025
Parexel
10,001+ employees
End-to-end clinical trials and regulatory consulting
No salary listed
No H1B Sponsorship
Remote in USA
Remote
Fully remote in the US; candidate must accommodate West Coast hours.
US Citizenship Required
 Data & Analytics (1) |
|---|
- 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.
- 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.
- 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.
Parexel provides end-to-end clinical development services for pharmaceutical, biotechnology, and medical device clients from Phase I to Phase IV. Its offerings include clinical trial management, regulatory consulting, and biostatistical analysis to support the design, execution, and analysis of clinical studies. The company operates as a CRO, partnering with sponsors to manage trials, ensure regulatory compliance, and generate robust data for drug development. What sets Parexel apart is its breadth of services across the trial lifecycle, emphasis on quality and reliability, and industry recognition, along with a focus on patient-centric approaches and leadership in gender partnership. The company’s goal is to help clients bring new therapies to market efficiently and safely by delivering high-quality, compliant trial outcomes and data that support regulatory submissions.
Company Size
10,001+
Company Stage
Acquired
Total Funding
$8.5B
Headquarters
Durham, North Carolina
Founded
1982
Simplify's Take
What believers are saying
- Rob Goodwin's September 2025 COO appointment scales AI integrations globally.
- Jim Anthony's August 2025 CCO role boosts biotech client growth.
- Paradigm Health partnership optimizes AI-driven trial efficiency and access.
What critics are saying
- IQVIA's AI platform erodes Parexel's biotech contracts within 12-18 months.
- Labcorp's Fortrea acquisition diverts 25% of Parexel's Phase II-III trials in 6-12 months.
- FDA rejects Vitrana-like tools, canceling Parexel's safety contracts in 6-12 months.
What makes Parexel unique
- Parexel acquired Vitrana for AI-enabled pharmacovigilance, integrating with safety databases.
- Parexel partners exclusively with Weave Bio, cutting NDA authoring by 60% using AI templates.
- Parexel publishes insights on 2026 FDA guidances for NAMs, biosimilars, and plausible mechanisms.
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Benefits
Flexible Work Hours
Hybrid Work Options
Company News
Parexel Off Campus Recruitment 2026 Drive for Freshers Hiring Associate - IT Service Desk | Apply now. March 12, 2026 Parexel Off Campus Recruitment 2026 Freshers Hiring - Parexel is offering its Off Campus Drive for 2026 Batch, providing excellent IT career opportunities for both fresh graduates & experienced candidates. If you hold a BE/B.Tech and have 0 - 3 years of experience, you could join Parexel as an Associate - IT Service Desk. For more information about Parexel Job Openings 2026, Check the below sections. Parexel Off Campus Recruitment 2026 Drive for Associate - IT Service Desk. | Company Name | Parexel Pvt Ltd India | | Job Role | Associate - IT Service Desk | | Qualification | BE/B.Tech | | Experience | 0-3 years | | Job Location | Hyderabad | | Source | www.parexel.com | Responsibilities - Parexel Off Campus 2026 * Provide first-line support to Parexel end users, clients, stakeholders, and partners via phone, chat, email and Self-Service tickets * Maintain 24/7 support for IT Infrastructure, Applications, and Site Services teams * Perform initial diagnosis and resolve tickets at the first level when possible * Accurately log and categorize all incidents and service requests in the ticketing system Escalate complex issues to appropriate Level 2 & 3 support teams * Adhere to established work instructions, SLAs, KPIs, and quality metrics * Own tickets from creation to resolution, ensuring timely updates to users * Perform remote troubleshooting to isolate and resolve issues * Foster positive communication between IT Infrastructure, Applications, and Operations teams * Apply acquired knowledge to improve IT practices and technologies Qualification & Skills Required - Parexel Jobs in Hyderabad 2026 * Excellent interpersonal, verbal, and written communication skills * Advanced problem-solving and analytical thinking abilities * Customer-centric approach with exceptional service orientation * Proficiency in incident and service request management * Experience in multi-channel support (phone, chat, email & Self-Service) for a global user base * Understanding of desktop support, PC hardware and software troubleshooting * Familiarity with Windows OS, MS Office suite application * Basic networking knowledge and understanding of IT infrastructure * Experience or Knowledge with remote support tools and software deployment technologies * Ability to multitask and prioritize effectively in a fast-paced environment * Team player with the ability to work collaboratively in a diverse environment How to apply Parexel Off Campus Drive 2026? * Candidates can apply for the Parexel Off Campus Recruitment for 2026 Batch through the link given below. Credit: Content Source From Parexel Official Website For more updates about Parexel Job Openings 2026, keep visiting this page and follow our Fresherstech.com website. You Can Also Check We are not associated with any Agency/ Organization /Company/Agent. Read our Disclaimer Policy and Term of Service for more information. All Company names, Brands & content are belongs to their respective owners & name is used in this website for identification purpose only. | Join Telegram | / | | Join Whatsapp Groups | / |
Parexel named "Best Contract Research Organization" at 21st annual Scrip Awards. Industry leader recognized for excellence and innovation in clinical development. RALEIGH, N.C., Dec. 12, 2025 (GLOBE NEWSWIRE) - Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world's life sciences industry, has been named "Best Contract Research Organization" in the Full-Service Provider category at the 21st annual Scrip Awards. This honor recognizes Parexel's continued excellence in partnering with biopharma companies to design, drive and execute all aspects of clinical trials as well as the company's vital contributions to drug development, patient impact and global public health. "This recognition belongs to all of our 20,000+ exceptional global colleagues who dedicate themselves daily to making real and meaningful differences for patients," said Peyton Howell, Chief Executive Officer. "Being named this year's 'Best CRO' reflects our commitment to advancing patient-guided clinical development and building strong and effective collaborations with our customers and site partners - all with the goal of accelerating the delivery of life-changing treatments to patients." Parexel was selected by an independent panel of distinguished judges as a result of its demonstrated excellence in delivering results that exceed sponsor expectations, innovations in patient engagement and recruitment, commitment to patient access and inclusion in clinical trials, and the ability to leverage AI to improve speed and quality of the clinical development process. The Scrip Awards, organized by Citeline, bring together over 400 industry leaders to honor and celebrate the best innovations and achievements in the global biopharma landscape from the past year. Open to any research-based pharmaceutical and biotech company worldwide as well as service providers to the pharmaceutical industry, the Scrip Awards recognize winners across diverse categories encompassing a wide range of industry achievements, with entries reviewed by independent judges. Winners were announced at the Scrip Awards ceremony on Dec. 11 in London. About Parexel Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world's life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, its 24,000+ professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind - broadening access and making clinical research a care option for anyone, anywhere. Its proven track record spans 40+ years and drives Parexel forward, advancing clinical research in healthcare's most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Its insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients - With Heart.(TM) Parexel continue to earn recognition industrywide, including the 2025 Scrip Award for "Best Contract Research Organization - Full-Service Provider," 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships. For more information, visit parexel.com and follow Parexel on LinkedIn, X, Facebook and Instagram. Media Danaka Williams +1 984 298 4207 [email protected] Addison Stallings +1 984 833 6362 [email protected]
Parexel leaders emphasize AI, workforce evolution in clinical research. Sponsored By Parexel Nov 10, 2025 8:00am At Fierce Biotech Week, Parexel executives Judith Millard and Sheela Hegde highlighted the transformative role of artificial intelligence and workforce development in clinical research. Millard, vice president and enterprise account leader at Parexel, and Hegde, managing partner and global head at Health Advances, a Parexel company, discussed how the industry is adapting to an influx of data from wearables, real-world sources and claims. This "avalanche of data," as Hegde described it, is driving the need for advanced analytics and AI-powered tools to accelerate trial design and patient enrollment. Parexel recently announced partnerships with Paradigm Health and Weave Bio to enhance its AI capabilities. These collaborations aim to streamline clinical trial processes and improve patient targeting, while maintaining regulatory compliance. Hegde noted that regulators are increasingly embracing AI, which she called "very timely" for the industry. Both leaders stressed the importance of evolving the clinical research workforce to meet these technological demands. Millard emphasized the need for a culture that encourages curiosity and psychological safety, allowing employees to ask questions and explore new approaches. Parexel is integrating AI experts into project teams and offering mentorship through its AI Center of Excellence. Training programs now focus on hands-on experience with AI tools, critical thinking and adaptability. Hegde said the industry must move beyond traditional training models to prepare talent for real-time decision-making and complex trial designs. Looking ahead, Millard and Hegde urged organizations to embrace change and foster innovation. "If we do this right," Hegde said, "we'll develop better medicines faster - and that's why we're here." Millard added, "Encouraging out-of-the-box thinking is key to driving meaningful progress." The editorial staff had no role in this post's creation.
Parexel announces AI partnership with Weave Bio to accelerate regulatory submission processes.
RALEIGH, N.C., Sept. 16, 2025 (GLOBE NEWSWIRE) - Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world's life sciences industry, today announced the appointment of Rob Goodwin as Chief Operating Officer (COO).