The 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, Clinical Data Management, this role provides a unique opportunity to use your knowledge of data management within clinical drug development, ensuring the provision of high quality data for all phases of clinical drug development.
In this role you will be expected to provide leadership and guidance as the Clinical Data Manager on one or more studies. 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 and quality requirements established for the project or study.
- Liaison between the CRO(s) and other functional team members for all issues related to data for assigned studies
- 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.
- Establish quality expectations for clinical data and ensure adherence throughout the duration of the studies)
- Mentoring and development of less senior data management staff
- Other activities as may be assigned
- At least 8 years of experience in Clinical Drug Development within the Pharmaceutical/CRO Industry
- Demonstrable leadership, project management, and interpersonal skills
- Experience working as a Lead 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 as part of a cross-functional team, in a fast-paced environment
Education & skills
- BSc/BA or equivalent work experience. Life sciences background
- Proven leadership skills
- Experience of project managing data management activities for a clinical study, including overseeing the development of timelines and resource plans.
- Understanding of data processing requirements for both clinical and laboratory data
- Excellent written and verbal communication skills
- Attention to detail
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.