Parexel is a global leader dedicated to improving world health through clinical trials, regulatory consulting, and market access solutions. With a shared goal of enhancing healthcare, Parexel empowers its teams to contribute meaningfully toward the development of therapies that improve patient lives. Join Parexel, where empathy and commitment drive a culture of excellence.
Responsibilities in Job
As a Data Management Lead II at Parexel, you will play a pivotal role in driving clinical project success. Your responsibilities include:
- Project Management:
- Develop and manage timelines for study data deliveries such as Go-Live, Interim Deliveries, and Final Database Lock.
- Act as the single point of contact for Data Management deliverables, ensuring timeliness, quality, and financial compliance.
- Coordinate cross-functional teams during database setup, study conduct, and close-out.
- Risk Management:
- Identify risks, define mitigations, and resolve issues with stakeholders.
- Analyze study metrics to ensure study health and compliance with service level agreements.
- Quality Assurance:
- Ensure compliance with ICH/GCP guidelines, SOPs, and inspection-ready Trial Master File maintenance.
- Address quality issues, drive corrective actions, and share lessons learned across programs.
- Financial Oversight:
- Manage project-level resources, ensuring alignment with the budget and resource forecasts.
- Resolve root causes of project variances and negotiate scope changes as needed.
- Client Engagement:
- Participate in bid pursuits, prepare tailored presentations, and portray Parexel’s operational expertise.
- Training and Mentorship:
- Deliver project-specific training to team members and mentor junior colleagues.
- Company Initiatives:
- Contribute to company initiatives by providing Data Management feedback and ensuring system data accuracy.
Qualifications
- Bachelor’s degree in a science or clinical-related industry.
- Strong clinical research industry experience.
- Proven track record of leading project and program teams.
- Understanding of ICH-GCP guidelines, local regulatory requirements, and study-specific procedures.
- Knowledge of SDTM/CDISC/CDASH standards is advantageous.
Skills
- Strong leadership and collaboration skills for global team management.
- Exceptional negotiation and problem-solving abilities.
- Proficient communication skills tailored for diverse audiences.
- Adaptability to changing environments and swift learning of new technologies.
- Proficient in clinical trial data management systems (e.g., InForm, Rave, Veeva) and Microsoft Office.
