Manager, Clinical Operations - Innovative Gene Therapies
Reporting To: Director, Clinical Operations
Location: Foster City, Ca
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
- 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, database lock, etc
- Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, 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, ensuring data management is properly for the study activities
- Ensures accurate maintenance and archiving of study records
- Oversees (e)TMF
- Management of study budget and timelines
- Management of vendors to the required standards
- Other activities as may be assigned
EDUCATION & SKILL REQUIREMENTS:
- Msc/PhD in life sciences
- Strong 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 fiel
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to 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.