What are the responsibilities and job description for the Sr. Manager/Associate Director Clinical Operations position at Delix Therapeutics?
Company
This is an exciting opportunity for a Sr. Manager / Associate Director level Clinical Operations professional who is interested in providing operational leadership for Delix Therapeutics’ clinical programs. This position will work closely with the Head of Clinical Operations to ensure key deliverables are met for assigned studies. This is an opportunity to work across multiple phases of development and have a direct impact on helping Delix to achieve important corporate milestones. The ideal candidate is a self-starter with a positive attitude who can adapt quickly.
Essential Responsibilities and Duties
- Support the Head of Clinical Operations and development team in the planning and execution of all aspects of clinical trial operations
- Lead the clinical project team on delivery of assigned clinical trials, including the planning, execution, and management of clinical trials from initiation to completion, ensuring that quality, timelines, and budgets are met
- Collaborate with cross-functional teams, including clinical operations, clinical science, regulatory, and data management, to ensure the successful implementation of clinical trial protocols
- Manage study documentation, including all applicable study operational plans
- Foster strong relationships with key stakeholders, including CROs, investigators, and study sites
- Manage internal processes for approval of vendor contracts, purchase orders, and invoices
- Assist with accurately updating and maintaining systems that track study documents, site compliance, and performance within project timelines
- Ensure study compliance with Delix’s SOPs and regulatory guidelines by performing periodic quality control audits of the electronic trial master file (eTMF) throughout all study phases including study initiation, implementation, and closure
- Maintain current knowledge of applicable US and international clinical regulations, standards, and guidance documents including ICH and GCP
- Provide mentorship / guidance to junior team members or cross-functional colleagues on study processes / study requirements
Minimum Requirements
If you are a local (Boston area) candidate and meet our requirements we look forward to reviewing your application.
Delix is an equal opportunity employer committed to a diverse and inclusive work environment.
Recruitment and Staffing Agencies : Delix Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Delix or its employees is prohibited unless contacted directly by Delix Talent Acquisition Team
