35Pharma is a fast growing, values driven biotechnology company based in Montreal, Canada, and we are currently looking for a full-time proactive, positive and self-motivated Clinical Project Manager / Senior Clinical Project Manager who will join our growing team to develop medicines that radically transform patients’ lives.
This is a newly established position to help progress our innovative drug programs into clinical development. In close collaboration with our medical, CMC and translational experts you will liaise with clinical vendors to start up and execute clinical trials and support the accompanying biomarker program with a shared commitment to high quality and performance. This is preferentially an office-based position in Montreal, Canada, but remote options may be considered.
This is a high growth opportunity with the potential for gradually increasing scope and responsibility within the role and function. The position would be an excellent fit for a clinical trial professional with demonstrated experience supporting Phase 1 and 2 clinical trials seeking to advance their career and be part of a team of dynamic drug development experts with a passion for bringing medical innovation to patients.
You will love this job if:
- You have a passion for science and drug development
- You thrive in a fast-paced environment with lots of responsibility and opportunity to learn
- You enjoy working as a team player and value good communication
Key Responsibilities:
- Lead, facilitate, coordinate, create and drive timelines for clinical study start-up / execution and related day-to-day activities required to ensure the project is completed on time, successfully and in a manner consistent with organizational goals as well as compliant with applicable regulations, guidelines, and corporate SOPs
- Serve as Sponsor point of contact for external CROs, regulatory and GCP quality vendors
- Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study close out
- Liaise with internal medical, CMC and translational teams on items related to study start-up, conduct, quality etc. as required
- Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual etc.
- Provide oversight of clinical vendors who are delegated responsibilities
The successful candidate will exhibit the following minimum profile:
- Minimum of three years of related work experience is strictly required, ideally in a biotech / pharma or CRO setting
- Minimum of BSc or related degree within Life Sciences, Clinical Pharmacology, Experimental Medicine, or a related field
- Documented GxP experience
- Flexible, independent, and self-motivated, able to handle multiple tasks and priorities
- Strong verbal and written communication skills, very comfortable assertively managing external vendors
Any of these qualifications in addition would be considered a significant advantage:
- Documented experience supporting early-stage clinical trials including Healthy Volunteer Phase 1 trials
- Significant and documented experience with clinical quality management including authoring and managing SOPs and quality systems
- Significant and documented experience authoring regulatory documents and managing their submission / interface with regulatory agencies
- Experience with translational medicine / use of central labs and other outsourced biomarker analyses, clinical sample management
- Biotech or other start-up experience
- Candidates with demonstrated significant experience may be eligible for Senior Clinical Trials Manager or Director of Clinical Operations
Perks:
- Comprehensive group insurance plan
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A team and culture committed to learning and high performance
Contact:
If you have questions about the position, you may contact Julia Schoelermann (julia@35pharma.com). Once you are ready to apply, please submit your documents to careers@35pharma.com – we are looking forward to hearing from you!
Key words:
Clinical Operations, Clinical Science, Drug Development, Phase 1, Regulatory, Quality, Study Start-up
