What are the responsibilities and job description for the Clinical Operations Manager position at ZS?
ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people—a fact that’s reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond.
The Clinical Operations Manager is a part of the EGOR team, responsible for supporting study implementation and ensuring each study is in compliance with the protocol, Good Clinical Practices, regulatory requirements (ISO 14155, FDA 812), and ZS standard operating procedures. Working with the Clinical Research Coordinator and Director of Clinical Research you will own administrative day-to-day project activities that support one or more clinical trials.
Responsibilities
- Experience in documenting and maintaining clinical trial operation workflows, both in traditional and decentralized studies
- Assist in writing, submitting, and revising IRB applications
- Create and maintain entries in clinicaltrials.gov
- Working with our VARA e-clinical system operations team to communicate protocol requirements for appropriate study setup and configuration
- Regularly interact with high-level internal and external stakeholders to coordinate the accomplishment of study and business needs
- Plan, coordinate, and arrange study communications and critical meetings on and off-site with both internal and external attendees, as well as drafting meeting agendas and detailed meeting minutes
- Set up, update, maintain and close Trial Master Files
Qualifications
- Bachelor’s degree is required
- Trained in Good Clinical Practices and certification in clinical trial management
- Minimum of 2 years in clinical validation for medical devices
- 3-5 years of experience in clinical trial execution
- Previous experience working with CROs and/or AROs
- Experience with preparation and submission of agency-level study documentation, for example FDA, CMS
- Familiarity with the drafting process for study documents (for example, protocols, ICFs, study plans)
- Prepare presentation materials for internal and external meetings. Draft meeting agendas and minutes
- Preferred experience in digital health, digital therapeutics, digital medicine outcomes research
- Ability to manage multiple tasks concurrently and to prioritize work appropriately
- Excellent organizational and communication skills, strong attention to detail, and ability to pick up new research-related skills quickly.
ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable.
Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. We are an Equal Opportunity Employer.
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