Manager, Translational Research and Operations - 2370
What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.
Editas Medicine is seeking a detail- and goal-oriented Operations Manager to join the Translational Research and Operations Team. The Operations Manager will be responsible for the management of bioanalytical CROs involved in clinical stage gene and cell therapy programs. The Operations Manager will ensure that bioanalytical assays (including non-GLP, GLP, GCLP, CLIA-regulated assays) are successfully transferred, qualified, or validated at CROs and implemented for non-clinical and clinical study support. The individual will work closely with clinical operations, data management and other stakeholders to ensure critical timelines are met by vendors. The individual will be responsible for communicating with bioanalytical CROs to track patient samples, review data output, and review and resolve any sample collection issues. The ideal candidate will have bioanalytical assay development, vendor oversight, and project management experience with clinical programs.
- Manage CROs to ensure that bioanalytical assays are successfully transferred, qualified, or validated at CROs and implemented for non-clinical and clinical study support.
- Collaborate with Clinical Operations to track site initiation, patient enrollment, and sample collections to ensure timely communication with bioanalytical CROs for upcoming sample shipment and analysis need.
- Request, coordinate, and track shipments for real time, batch, and specialty sample analyses.
- Coordinate sample analysis and data transfer with the data management team to ensure timely TLF generation.
- Answer queries from sites on upcoming collections through ClinOps.
- Review any relevant ICF queries with ClinOps.
- Review LSA/QRC/Lab manual documents for correct content on sample collection, assay execution, and data transfer.
- Review DTA in collaboration with data management to ensure all parameters and results are captured correctly.
- Review data and reports for accuracy.
- Manage study documentation at bioanalytical CROs such as study plan amendments, stability testing, and clinical sample testing plan.
- Coordinate with assay SMEs to lead assay specific discussions with CROs.
- Document, review, and resolve sample collection issues with ClinOps.
- Work with the Finance team to implement and track the Bioanalytical CRO budgets.
- Bachelor’s degree with 6-8 years of experience in an industry setting.
- 5+ years hands-on experience managing CRO activities.
- Experience with the development of bioanalytical assays preferred.
- Hands-on experience working in a regulated (CLIA / GLP / GCLP) environment is a plus.
- Project management experience and familiarity with project management tools such as Smartsheet and ClinTrak desirable.
- Excellent communication and presentation skills as well as organizational aptitude.
- Attention to detail and ability to work under tight timeline.
- Ability to work cross functionally efficiently, influence without authority, and manage conflict
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
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