When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Title: Data Management Lead - Oncology
Location: LATAM (Mexico, Brazil, Colombia or Argentina)
About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
Who You Are:
Required:
- BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
- 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics
- Medical affairs experience is a plus, but not necessary
- Experience in (Phase IIIB - IV trials experience) is a plus
- Late Phase Oncology, ideally women's health solid tumor is a plus
- Strong project management experience and Vendor/CRO oversight
- 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:
- Understanding data structiure and programming languages such as SAS, R, Python, and SQL, and advanced analytics approaches (e.g., machine learning, AI).
- Understanding and/or 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).
- Understanding and/or 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.
What you will be doing:
Responsibilities will include:
- 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.
Cross-functional Data Management Leadership:
- 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.
Project Financial and Resource Management:
- 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.
Company Initiatives:
- 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.
Training:
- 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.