Manager, Clinical Data Management

Manager, Clinical Data Management

Location: London

Reporting to: Director, Clinical Data Management

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Orchard is a fast-growing and well-funded company with ground-breaking science and a broad pipeline that includes several assets in early and late stage clinical development.

The Manager, Clinical Data Management at Orchard Therapeutics is a key member of the cross-functional team within the Clinical Operations and Data Management Department, accountable and responsible for managing the end-to-end delivery of data management services, collaborating with internal and external customers whilst ensuring timely delivery and all regulatory requirements and guidelines are met. 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.

Responsibilities

In this role you will be expected to provide leadership and guidance, as the Lead Data Manager to plan and manage data management activities across multiple studies or projects and 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.
• Act as the liaison between the CRO(s) and other functional team members for all issues related to the data for assigned studies
• Development and/or review of case report forms, study database structure, data management, quality plans (including edit checks) and study timelines
• Input into protocol, data standards, statistical analysis plans as required
• 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 staff
• Ensuring operational efficiency and excellence by overseeing and/or assisting in the creation and documentation of new or revised department procedures.
• Other activities may be assigned as required

Requirements

Job Requirements

• At least 8 years of experience in Clinical Drug Development within the Pharmaceutical/CRO Industry
• Self-starter with the ability to work on a cross-functional team, in a fast-paced environment
• 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

Education & skills

• BSc/BA or equivalent work experience. Life sciences background

• 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
• Proven leadership skills

For further information on this role do not hesitate to email HR@orchard-tx.com

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.