Clinical Data Manager

hace 1 semana


Colombia Syneos Health, Inc. A tiempo completo

Company Overview

Syneos Health, Inc. is a leading biopharmaceutical solutions organization dedicated to accelerating 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 make Syneos Health easier to work with and easier to work for.

We 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 about changing lives.

Why Syneos Health

We are passionate about developing our people through career development and progression, supportive line management, technical training, peer recognition, and total rewards programs.

We commit to our Total Self culture – where you can authentically be yourself.

Our Total Self culture unites us globally, and we dedicate ourselves to taking care of our people.

We build the company we all want to work for and our customers want to work with.

Job Description

Job Responsibilities:

  • Acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables.
  • Coordinates the work of the assigned Data Management/Data Operations team.
  • Ensures launch, delivery, and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
  • Provides 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.
  • Monitors and communicates project/program progress to the Sponsor and project team.
  • Supports the management of resources on assigned projects/programs.
  • Plans, manages, and requests resources for assigned projects.
  • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date.
  • Participates in and presents at internal, Sponsor, third-party, and investigator meetings.
  • Plans for and creates necessary documentation to support internal and external audits.

Required Skills and Qualifications:

  • Bachelor’s degree in biological sciences or related disciplines.
  • Clinical data management experience or 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.
  • Knowledge of ICH/GCP regulatory requirements for clinical studies.
  • Effective oral and written communication skills.

Estimated Salary Range: $80,000 - $120,000 per year


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