drjobs Sr. Clinical Data Manager

Sr. Clinical Data Manager

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1 Vacancy
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Job Location drjobs

Princeton, NJ - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:
  • Manage all data management activities according to quality standards and regulatory requirements ensuring adherence to project timelines and budget.
  • Oversee the development of CRFs and CCGs with other functional area representatives ensuring all data management databases are developed and validated.
  • Manage interactions and deliverables with third-party vendors and CROs ensuring proper execution of data management activities and providing relevant metrics to the study team.
  • Oversee data review reconciliation and cleaning activities for all assigned studies.
  • Ensure high data quality by adhering to corporate industry and regulatory standards.
  • Monitor outsourced data management activities for efficiency and regulatory compliance providing feedback on vendor selection.
  • Cultivate effective working relationships with colleagues junior staff vendors and management solving problems and escalating issues with proposed solutions as needed.
  • Educate clinical team members on data management processes workflow and data standards.
  • Review and provide input on protocols SOPs and work instructions for the data management department.
  • Perform ongoing review of study documentation in the trial master file to ensure audit readiness.
  • Perform other related duties as required and assigned.
Requirements:
  • Bachelors degree or equivalent combination of education 7 years of relevant experience in clinical data management within biotech or pharmaceutical/drug development.
  • Preferred experience in vendor management and global operations.
  • Ability to work effectively in a smaller company environment particularly in early development roles.
  • Strong planning and project management skills including risk assessment and contingency planning.
  • Effective communication and interpersonal skills.
  • Ability to work as a team player in a complex changing environment.
  • Self-motivated independent and results oriented.
  • Excellent organizational and problem-solving skills with attention to detail.

Employment Type

Full Time

Company Industry

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