Senior Trial Master File Operations Associate, Clinical eTMF Operations

WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global, late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis, along with partnered programs including glycogen storage disease type III, and hepatitis B virus. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., and the Cystic Fibrosis Foundation.

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.

THE OPPORTUNITY

Reporting to the Manager, Clinical eTMF Operations, the Electronic Trial Master File (eTMF) Sr. Trial Master File Operations Associate is responsible for assisting with internal oversight, management, and support of the Arcturus eTMF. The eTMF Sr. Trial Master File operations Associate will also support eTMF maintenance, user support, and assist with refining TMF department guidance documents under the guidance of the Manager, Clinical eTMF Operations.

WHAT YOU WILL CONTRIBUTE

Supporting Sponsor Tracking and Oversight of Clinical Development Activities:

• Communicate eTMF health and findings to Arcturus project teams and CROs
• Upload documents in eTMF
• Track the TMF review schedule for all studies. Keep internal and external study teams on review schedule
• Track study lifecycle status for all studies in which Arcturus is responsible or will be responsible for the TMF
• Assist in running eTMF health checks and communicating, findings/reports to the project team and CROs
• Provide first level of guidance to project teams in risk-based site reviews
• Provide first level of user support in Veeva Vault – Clinical
• Work with the manager of clinical eTMF operations to refine best practices and uphold a consistent, cohesive communication approach to all internal and external project teams
• Lead the charge on keeping the TMF lifecycle on track throughout all study phases
• Track system user experiences and provide feedback, to TMF Manager, to help create a better user experience in Veeva
• Collaborate on SOPs, job aides, and work instruction updates and creation
• Assist with refining TMF lifecycle from study start up to close out and archival
• Assist with TMF transfers from various project stages and in varying timelines
• Attend TMF related meetings across internal and external projects
• Build agendas, maintain minutes and track follow up items
• Assist in archival of study documents
• Track user accounts on schedule, according to the corresponding TMF plan
• Send final inventory reports to the internal and external clinical operations leads for final archival approval
• Assist with Veeva Vault bulk uploads during eTMF migrations
• Perform eTMF transfer quality and completeness checks when transferred from CROs or external vendors
• Support internal and external teams keep document integrity while following GCP guidelines for strong TMF documentation
• Guide study teams to keep reviews on track and to completion
• Work with Veeva managed services to implement and follow change management for quarterly system releases and changes to the user interface based on user feedback

WHAT WE SEEK

• Minimum of bachelor’s degree in scientific or related discipline
• At least 3 years of TMF experience required, including experience in study start-up, study maintenance and document quality reviews. At least 5 years of clinical trials experience
• Experience working with the TMF DIA reference model and a deep understanding of its structure as it relates to maintaining study documents
• SOP and Job aide preparation experience, preferred
• CITI trained, preferred
• Familiarity with Veeva vault
• Demonstrated working knowledge of the pharmaceutical industry including ICH/GCP guidelines
• Excellent communication (oral and written), organizational, and problem-solving skills
• Detail-oriented, with good organizational, prioritization, and time management proficiencies to work on multiple projects simultaneously.
• Familiarity with title 21 CFR regulations

EDUCATION

• Minimum of bachelor’s degree in scientific or related discipline

WHAT WE OFFER

At Arcturus Therapeutics, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Our total rewards package includes:

• Full range of health benefits including Medical, Dental & Vision with 100% EMPLOYER PAID premiums for employee and family!
• 401k Match
• Employee Stock Purchase Program (ESPP)
• Competitive salaries and bonus plans plus equity via Stock Options
• Catered lunches
• Free variety of snacks and beverages
• Health and Wellness programs
• $100 Anniversary cash awards with opportunity to increase to $2000!
• Referral Bonuses
• On Campus Gym
• Company sponsored FUN events
• Education reimbursement

The anticipated salary range for candidates who will work in San Diego is $80,000 to $100,000.

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Arcturus Therapeutics is multi state employer and this salary range may not reflect positions that work in other states. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com

Arcturus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.