Associate Director, Clinical Operations
Posted on 4/28/2022
Google Cloud Platform
- Bachelor's degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution is strongly desired
- Ideal candidate will have at least 8 years of relevant experience in managing clinical trials (minimum 4 years of managerial experience) in sponsor organizations with a strong track record of successful trial initiation and execution
- Demonstrated ability to independently manage the initiation, monitoring and closing of clinical studies
- Demonstrated extensive understanding of clinical trial processes, and technical expertise in driving execution, from study start-up through study closure
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
- Thorough knowledge and understanding of FDA and/or EMA regulations (or relevant local regulations), ICH Guidelines and GCPs governing the conduct of clinical trials
- Working experience with an electronic data capture system, CTMS system, and eTMF system
- Strong interpersonal communication (written and verbal), organizational and prioritization skills
- Able to work effectively under a fast-paced and changing environment
- Strong work ethic and demonstrated ability to deliver assignments on time
- Proficient with office automation tools, such as Microsoft Office and the Google suite of apps
- Oversee execution of all operational aspects of one or more clinical studies
- Oversee the identification and mitigation of study risks to study implementation, enrollment, conduct, and compliance
- Provide operational input in site selection, protocol development, data collection, study timeline, and study budget
- Leads the study team through the vendor selection process and serves as an escalation point for any CRO vendor related issues
- Participates in the development of Clinical Operations and cross functional SOPs and provides strategic direction in the development and implementation of process changes
- Identify and provide solutions and direction related to key cross-functional, site, and CRO clinical study issues
- Ensure operational feasibility of clinical study plans and scenarios, including timeline, budget and resource requirements
- Determines participant recruitment strategies, operational feasibility and implementation path of the study/program objectives; manages and communicates to senior management and key stakeholders
- Oversee the quality of clinical programs and deliverables and ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs
- Lead the team through inspection readiness activities and address any audit findings appropriately and promptly
- Recruits, hires, mentors, and manages CPA, CTM, and CPM direct reports, and supports their professional development
- Provides leadership, guidance, and direction to the Clinical Operations study team
- Clinical Operations representative in cross functional working groups and study team meetings
- Partners with key stakeholders such as Legal, Finance, Biosample Management, Clinical Data Management, Regulatory Affairs, Compliance, and Clinical Development
Designs cancer screening tests
GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
- Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
- Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
- Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
- Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.
- Grit - We are determined and resilient because patients are counting on us.
- Respect - We value diversity and challenge each other respectfully.
- Accountability - We own our decisions and keep our commitments.
- Integrity - We adhere to our principles of humility, transparency, and rigor.
- Leadership - We make each other better by making leadership everyone’s responsibility