Temporary - Clinical Trials Manager
About The Position
NantWorks (the “Company”) is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow’s opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries. The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed. Position Summary The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Requirements
- Bachelor’s degree in biological science with 5+ years of relevant experience in clinical research required
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
- Understand the job-specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents.
- If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
- Maintain corporate confidentiality at all times.
Responsibilities
- Assist in the development and management of company-sponsored clinical trials
- Assist in reviewing completed assignments by members of the clinical development group
- Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
- Provide support in site recruitment, site initiation, site payments and site close-out.
- Help to oversee the training of new clinical site staff or site training for protocol amendments.
- Liaise with the regulatory department for the collection of updated regulatory documents as needed.
- Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
- Assist in the training of clinical development group staff.
- Prepare and update clinical trial updates for Clinical Development team
- Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
- Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
- Performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
