Clinical Data Manager - P19-11


London, England, United Kingdom

Biostatistics

The Lead Clinical Data Manager at Orchard Therapeutics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Director Biostatistics, this role provides a unique opportunity to use your knowledge of data management within clinical drug development in ensuring the provision of high quality data for all phases of clinical drug development.

Requirements

Responsibilities

In this role you will be expected to provide leadership and guidance as the lead clinical data manager on one or more projects. You will be required to plan and manage data management activities across multiple studies or projects to deliver clinical and laboratory data to agreed timelines and quality.

Key responsibilities will include:

  • Management and oversight of clinical data management tasks outsourced to CROs, ensuring that their performance meets the agreed timelines, quality and budget requirements established for the project or study.
  • Development and/or review of case report forms, study database structure, data management and quality plans (including edit checks)
  • Input into protocol, data standards, statistical analysis plans
  • Act as key clinical data management contact for internal project team and external project partners.
  • Mentoring and development of less senior data management staff
  • Other activities as may be assigned

Job Requirements

Demonstrable leadership, project management, and interpersonal skills

Experience working as a clinical data manager, preferably in a drug development environment

Experience in managing and working with CROs and consultants in outsourcing data management tasks

Good knowledge of data management standards including database requirements and processing of clinical and laboratory data

Good understanding of CDISC standards

Understanding of medical coding requirements

Self-starter with the ability to work on a cross-functional team

Education & skills

  • BSc or higher
  • Experience working as a clinical data manager, preferably in a drug development environment
  • Understanding of data processing requirements for both clinical and laboratory data
  • Excellent written and verbal communication skills
  • Proven leadership skills

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.