Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early- to late-stage disease. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.
This role is a highly visible position and of significant impact to the company. You will be provided with a great opportunity to expand your knowledge and scope of a traditional TMF/Clinical Operations role. As a TMF Manager working as part of the Clinical Operations team, you will participate in study operational strategy and planning. We are on a critical mission to bring quality solutions to patients. This role will help us drive forward towards that pinnacle goal of truly putting patients first. Title commensurate with years of experience.
- You will take a primary clinical TMF role ensuring the required documents that reside in the trial master file (TMF) are always inspection ready according to regulatory requirements and Candel procedures.
- You will participate in the selection of an eTMF system and lead the implementation process.
- You will work with study team to define the TMF plan.
- You will help define the expected documents for the study and maintain appropriate placeholder(s) or Expected Document Lists in the eTMF system in collaboration with the study team.
- You will support manual TMF filing and mapping to an electronic TMF system.
- You will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies to support both the internal team, Strategic Partners and/or Clinical Research Organizations (CROs).
- You will exhibit strong project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
- You will participate in CRO and study vendor review, selection, and negotiation
- You will provide support for internal audits, and regulatory inspections.
- You support the health and execution of assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Candel SOPs).
- Bachelor’s Degree or equivalent required; Life Sciences preferred and 5-10+ years of relevant experience in the pharmaceutical industry and/or clinical research organization
- Experience with clinical trials, inspection and audit readiness, and working with vendors.
- You consider yourself a high achiever with a “can do” attitude. You don’t mind rolling up your sleeves and pitching in. You always go above and beyond.
- You have a thirst for learning. You relish in sharing knowledge and know how to have fun doing so!
- You are comfortable taking risks and (appropriately) pushing boundaries.
- You are self-aware, humble and have a good sense of humor.
- You build genuine relationships. You trust your co-workers. You truly enjoy working together and understand we are all more successful when we work as a team.
A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large. Please visit www.candeltx.com for more information.
We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology. For consideration, please submit CV.
Interested candidates please submit your resume to email@example.com