Our Culture: Why work with us?
We value the diversity of backgrounds, ideas, opinions, and life experiences that our team members bring to Candel. There’s a dedication to one another that’s palpable. We hire kind, smart, creative, trusting, passionate professionals who are always learning, and teaching and putting the patient first. We’re incredibly proud that as we’ve grown, our vibrant culture has remained steadfast. We continue to build a culture of collective hard work without egos, instilling mutual trust and accountability. Our Leaders are accessible, authentic, and invest in their employees. We believe in giving team members freedom with accountability”, meaning our focus is on results, not where and when employees work. “We’re all in this together,” is our company motto.
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. We have a robust pipeline with clinical assets in phase 1, 2 and 3 for the treatment of 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.
What’s in it for you:
This is a highly visible role and you will have primary responsibility for all aspects of data management for clinical studies and will provide leadership and data management expertise to our study teams. This includes managing third party data management vendor activities which can include development of data management plans, database development and validation.
A day in the life of this role:
- Manage all aspects of data management for clinical studies for new and ongoing clinical trials.
- Manage third party data management vendors activities including timelines, database build, review of data transfer specifications, data cleaning, query management, reconciliation and ensuring transfers and data delivery.
- Participate in reviewing request for proposals and providing feedback (SOW, budgetary, contractual) for the data management vendors.
- Provide input on clinical study protocols and other clinical trial documents
- Provide input for key clinical data management deliverables, including: Case Report Form (CRF) design, annotation, database design specifications, data entry guidelines, data management plans, edit check specifications, validation check testing and approval, and electronic data transfer agreements with external vendors.
- Develop and identify improvements to SOPs and processes
- Represent data management on cross functional teams, providing study updates, timelines, communications of data management project status.
- Manage and participate in data review with clinical study teams, safety and biostatistics throughout the study
What will make you a good fit with this role:
- Excellent applied knowledge of GCP, ICH, 21CFR Part11 and other relevant regulatory guidelines and standards
- Strong project management skills and experience managing data
- Working knowledge of regulatory requirements for data management of clinical studies including Clinical Data Interchange Standards Consortium (CDISC) standards including SDTM and AdAM data submission standards.
- Experience with data clean-up and data preparation for NDA/BLA submissions
- Knowledge of SAS and statistical programs used for analysis
- Understanding of HIPAA and the importance of patient data privacy
- Excellent written and verbal communication skills
- High attention to detail and data accuracy
- proven ability to manage multiple projects, prioritize and thoroughly follow-up on assigned tasks.
- Perseverance: You have a “can do” attitude and don’t mind rolling up your sleeves and pitching in. You always go above and beyond.
- Intellectual curiosity: You enjoy thinking deeply. You have a thirst for learning. You relish in sharing knowledge and know how to have fun doing so!
- Daring: You are comfortable taking risks and (appropriately) pushing boundaries. You work hard and challenge the status quo.
- Comradery: 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.
What we’ll need from you:
- Bachelor’s degree with at least 7+ years or an advanced degree with at least 5 years of data management in the pharmaceutical industry or relevant experience.
- Experience in a small company is a plus.
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