Job description

Why Work for us?

At Virogin Biotech, every day we strive to achieve incredible progress by working together to pursue our shared mission in developing novel oncolytic immunotherapies/mRNA vaccines and improving the lives of our patients. With our vision to be a global, best-in-class oncolytic virus company and with our patients’ welfare always at the top of our priorities, our teams work together to create impactful drugs for cancer patients with the hope of solving one of the world’s biggest challenges - a future without cancer.

Position Overview

With this opportunity, you’ll join a team of diverse and dedicated problem solvers, continuously challenging each other to bring forward diverse perspectives and insights that ignite innovation and make a difference to the work that we do. We are seeking a highly motivated professional who is looking to grow their career with our company.

As a Clinical TMF Specialist you will be part of a growing team and be responsible for managing the life cycle of Trial Master File (TMF) activities for all clinical trials in North America (USA & Canada). The successful candidate will be knowledgeable in Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+) and ensure that TMF is inspection-ready at all times.

Responsibilities and work you’ll be part of

• Responsible for managing TMF activities from start-up to close-out for all clinical trials.
• Define and execute processes and activities to ensure that TMF is inspection ready at all times and in accordance with regulatory requirements, internal Standard Operating Procedures (SOPs) and the study specific TMF plans
• Support the clinical project teams to ensure TMF quality per International Conference on Harmonization (ICH) E6 (R2) guidelines
• Responsible for training study contributors to the study specific TMF for ongoing projects and filing study documents into the TMF in accordance with the index.
• Quality check on documents received and uploaded to the TMF by study contributors to ensure it meets ALCOA+
• Performs quality reviews of the TMFs for completeness

• Leads TMF reviews with the study team and works cross-functionally to ensure timely closures of quality review findings
• Communicate with stakeholders giving updates on the completeness of the TMF regularly while identifying and mitigating Good Documentation Practices (GDP) potential risks
• Assist in periodic internal TMF audits

Experience and Skills you’ll bring to the role

• Bachelor’s Degree in Health or Life Sciences
• 2-3 years’ experience with TMF, including experience in study start-up, maintenance, and closeout activities.
• Subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology.
• Demonstrated experience in TMF, Clinical Trial Management system (CTMS) and Electronic Data Capture (EDC) technologies
• Extensive knowledge of expected documents required for clinical trial
• Knowledge and application of ALCOA+, FDA regulations, Good Clinical Practice (GCP), and Good Documentation Practices (GDP) per ICH guidelines related to clinical document management (ICH E6 R2)
• Demonstrated understanding of the clinical study phases involved in drug development
• Strong attention to detail, organization, and problem-solving abilities

The following experiences or abilities are assets

• Experience working with a Contract Research Organization (CRO) or Sponsor Company

Working conditions

• Works remotely and will need to work flexible work hours
• Works with minimal supervision

Join Virogin Biotech’s team of creative and motivated professionals in making a difference to solve the world’s biggest challenges—a future without cancer. For more information about our company, visit www.virogin.com

Job Type: Full-time

Salary: From $60,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
COVID-19 vaccination is an employment requirement; accommodations will be considered upon request.

Education:

• Bachelor's (Required)

Experience:

• Trial Master File: 1 year (Preferred)
• FDA regulations: 1 year (Preferred)

Work Location: Remote

blackflymedia.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, blackflymedia.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, blackflymedia.com is the ideal place to find your next job.