Senior Clinical Data Management Lead

hace 2 semanas

Colombia Syneos Health, Inc. A tiempo completo

Job Summary

Syneos Health, Inc. is seeking a highly skilled and experienced Sr Project Data Manager to join our team. As a key member of our Clinical Data Management department, you will be responsible for leading and managing clinical data management projects from start to finish.

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 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

We are looking for a highly skilled and experienced professional with a strong background in clinical data management. The ideal candidate will have:

  • 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

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

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