Senior Clinical Data Manager

hace 4 semanas

Ciudad de México, Ciudad de México Syneos Health, Inc. A tiempo completo

Job Summary

Syneos Health, Inc. is seeking a highly skilled Sr Project Data Manager to join our team. As a key member of our Clinical Development model, you will be responsible for leading data management activities and ensuring the successful delivery of projects.

Key Responsibilities

  • Coordinate the work of the assigned Data Management/Data Operations team.
  • Ensure launch, delivery, and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
  • Provide project-specific training to internal and external audiences as required.
  • Responsible for financial management of assigned projects/programs, including revenue recognition, changes in scope, and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed.
  • Monitor and communicate project/program progress to the Sponsor and project team, including the use of project status reports and tracking tools/metrics to enable in-stream data collection and query management.
  • Support the management of resources on assigned projects/programs.
  • Plan, manage, and request resources for assigned projects.
  • Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
  • Maintain documentation on an ongoing basis and ensure that all TMF filing is up-to-date.
  • Participate in, and present at, internal, Sponsor, third-party, and investigator meetings.
  • Plan for and create necessary documentation to support internal and external audits; participate in such audits.
  • Train and mentor data management staff, act as a subject matter expert.
  • Prepare input for, and participate in, proposal bid defense meetings.
  • Maintain proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
  • Perform other work-related duties as assigned. Minimal travel may be required (up to 25%).

Requirements

  • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
  • Clinical data management experience or an equivalent combination of education and experience.
  • Experience in Clinical Data Management practices and relational database management software systems.
  • Strong project management skills and knowledge of project management methodologies.
  • Demonstrated staff leadership skills.
  • Contract Research Organization (CRO) experience preferred.
  • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
  • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
  • Effective oral and written communication skills.
  • Strong presentation skills.
  • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
  • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
  • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
  • Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management.

About Syneos Health, Inc.

Syneos Health, Inc. is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health, Inc.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

At Syneos Health, Inc., we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health, Inc. means your everyday work improves patients' lives around the world.

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