Description
Manager Clinical Operations
Location: London (Flexible)
Reporting to: Senior Director of Clinical Operations
Job Summary
Reporting to the Senior Director of Clinical Operations, the Clinical Operations Manager will be accountable for managing the clinical operation activities for 2 to 3 clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.
Key Elements and Responsibilities
- Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP
- Oversees the quality of the clinical operations for the studies he/she is in charge of
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
- Manages data management and statisticians ensuring data base maintenance, interim and final database locks.
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical triallogistics, applications (IRB, local agencies)
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
- Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
- Manages CRFs creation, implementation, collaborating closely with data management for the study activities
- Ensures accurate maintenance and archiving of study records
- OverseesTMF
- Management of study budget and timelines
- Management of vendors, including a CRO, to the required standards
Requirements
Required Knowledge
- Strong experience & knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH
- Experience working in an academic environment is a plus, as well as experience in orphan disease field
- Excellent organisational and communication skills;
- 'Can-do' attitude and willingness to be flexible
- BsC in life sciences
- Msc/PhD in life sciences is a plus
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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 Orch