Senior Clinical Trial Manager

Job not on LinkedIn

🕒 September 12

🏄 California – Remote

🏄 California – Remote

💵 $165k - $185k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• Oversee and execute operational aspects of one or more clinical studies from protocol development through database lock • Manage external vendors and contract research organizations • Prepare study documents according to ICH GCP and Artiva SOPs • Coordinate and oversee design of study materials, including CRFs, patient diaries, study participation cards, and source documents • Assist with protocol development, Investigator Brochure updates, and study report completion • Manage monitoring activities through contractors or CROs, including occasional on-site clinical monitoring or co-monitoring with a CRA • Provide guidance, direction, and management to CRAs directly or through CROs • Track patient enrollment; qualify, initiate, monitor, close out, and review clinical study sites • Assist with coordination of data management activities and data queries • Review study quality metrics and determine appropriate actions with the study team • Coordinate study supplies and review/approve investigational product release packages • Negotiate clinical trial service vendor contracts and support invoice reconciliation • Review informed consent forms, CRFs, and study-related materials • Plan and participate in investigator meetings • Assure regulatory compliance with Artiva SOPs, FDA regulations, and ICH guidelines • Ensure the trial master file is current and maintained

🎯 Requirements

• BA/BS, nursing degree, or advanced degree; degree in the life sciences preferred • At least seven years of experience in clinical trial management • Experience in Cell Therapy, Autoimmune or Rare Disease strongly preferred • Past management of people in a matrixed environment • Management of global clinical trials • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations • Ability to work independently and in a team environment • Approximately 25% travel required, with occasional international travel • Proficiency with MS Office, including Word, Excel, PowerPoint, and Outlook • Excellent oral and written communication skills • Strong organizational abilities

🏖️ Benefits

• Medical, Dental, and Vision • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Paid Time Off (PTO) • Company paid holidays, including the year-end holiday week • Bonus.ly recognition program, where points can be traded for desired items • Entrepreneurial, highly collaborative, and innovative environment • Passionate, tenacious, innovative, transparent, and inclusive company culture