Director/Associate Director, Clinical Operations
Concord, MA
The Director/Associate Director should have experience with all aspects of advancing a clinical study through each phase of clinical development. This position will also ensure that the clinical stage programs achieve the program objectives within the established timelines, budget, and quality standards. Working together with clinical operations leadership, the individual will assist in the assurance that the appropriate company infrastructure and associated systems are in place to support a Tremeau clinical trial. In this role, she/he will lead the execution of the clinical trials in conformance with Good Clinical Practices (GCPs), International Conference of Harmonization (ICH) Guidelines and Tremeau’s Standard Operating Procedures (SOPs). The Director/Associate Director will report to the Executive Director of Clinical Operations at Tremeau. This position can be located remotely. Travel to the Tremeau home office in Concord, MA, will be required at specific times when the COVID-19 pandemic no longer requires travel or in-office restrictions.
Key Responsibilities
- Provide oversight of day-to-day activities for one or more clinical trial(s) and CRO(s), including but not limited to data management, clinical monitoring, and clinical trial site regulatory activities. Assist clinical operations leadership in ensuring performance of CROs and other external members of the clinical trial team
- Assist with the creation of clinical operations SOPs, systems and processes across the trials; ensure compliance with regulatory and other applicable standards and guidelines
- Ensure all aspects of the clinical trial are conducted according to SOPs, applicable regulations, and CFR, ICH, and GCP guidelines
- Ensures that external vendors are selected and managed to deliver within the established timelines and budget. This also includes site qualification
- Assist with the creation of timelines and budgets, and manage trials to meet these targets
- Review trial expenses and external invoices for accuracy. Assist finance as needed
- Prepare and present project updates, both written and oral presentations
- Develop training materials and conduct trainings on various aspects of clinical study conduct
- Contribute to the development of clinical trial processes and documents, and oversight plans. Implement and manage processes to ensure compliance
- Conduct ongoing clinical data review and ensure data quality
- Work with cross-functional internal and external team members, including those in quality
Requirements
Tremeau offers a competitive salary and benefits package. To apply, please fill out the information below or send your resume to careers@tremeau.com and include the job title in the subject line. No recruiters please.
