35Pharma is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.
Role:
The Associate Project Manager (APM) will be responsible for successful management of clinical trial activities to ensure compliance with the clinical development plans, budgets, and timelines, as well as all applicable regulations, guidelines, quality industry standards, and internal standard operating procedures (SOPs) and policies. The APM will provide project management support to the Clinical Project Managers in planning, organizing, documenting, tracking and managing day to day clinical trial and regulatory activities.
Main responsibilities:
· Coordinate and track timelines for clinical trials start-up, conduct, close-out, and related day-to-day activities to ensure the project is completed successfully on time and in compliance with organizational goals and timelines, applicable regulations, International Council for Harmonisation (ICH) Guidelines, Good Clinical Practice (GCP), and SOPs/policies.
· Serve as back-up to Clinical Project Managers as Sponsor point of contact for external contract research organizations (CROs), vendors and sites.
· Facilitate and/or track the preparation / review / completion of interdisciplinary project tasks including regulatory submissions, trial master file (TMF), clinical monitoring, site inspections/audits, site management, case report form (CRF) / clinical database, data collection / review, pharmacovigilance, medical monitoring, statistical analysis, medical writing, and vendors selection / set-up / management.
· Liaise with internal functional teams during the course of the project to ensure project tasks are completed in compliance with organizational goals, quality standards, approved timelines, and within budget.
· Support the preparation, review, and updating of documents related to clinical
development such as clinical trial protocols, informed consent forms, Investigator's Brochure, laboratory manual, pharmacy manual, etc.
· Support the Clinical Project Managers in the set-up and management of clinical vendors.
· Collaborate with the Clinical Project Managers to create, review, and maintain effective project plans ensuring milestones, deliverables and timelines are met and within budget.
· Maintain study budget, completion of tasks (actual vs projected), and timelines in collaboration with the Clinical Project Managers.
· Participate in the planning and conduct of investigator's meeting.
· Support the Clinical Project Managers and TMF Specialist in day-to-day activities related to TMF set-up, maintenance, and reconciliation at the end of the study.
· Track clinical monitoring and remote monitoring activities (i.e., monitoring calendars, monitoring report review process) and support Clinical Project Managers in day-to-day clinical trial management activities.
· Assist the Clinical Project Manager and Legal department (as applicable) in the negotiation and management of study budgets and Clinical Trial Agreements.
· Review and track investigator’s payments in collaboration with the Clinical Project Managers and finance department.
· Set-up and maintain investigators database.
· Coordinate and track sites selection activities (i.e., non-disclosure agreement, feasibility questionnaire, site qualification visits).
· Coordinate and track site activation start-up activities (i.e., clinical trial agreement, budget, Institutional Review Board (IRB) / Independent Ethics Committee (IEC) submissions and tracking, essential documents review and collection).
· Review and maintain the risk management plan and other study plans in collaboration with the Clinical Project Managers.
· May conduct remote monitoring activities (i.e., remote data review, investigator site file (ISF) reconciliation).
· May contribute to any clinical and regulatory operations project activities as deemed necessary to ensure the clinical program success.
Qualifications:
· Minimum of bachelor's degree in health sciences or related degree within life sciences or equivalent experience.
· Minimum of 3 years of experience in a pharmaceutical, biotechnology company, or a contract research organization (CRO), in a clinical project coordinator or APM role in clinical trials.
· Proficiency in required software (Word, Excel, Power Point or Keynote, MS Project or Smartsheet) and computer skills.
· Proficiency in other clinical systems (i.e., electronic data capture (EDC), eTMF, Quality Management System (QMS)) an asset.
· Previous clinical monitoring experience conducting on-site and remote monitoring visits an asset.
· A self-starter and comfortable with broad responsibilities in an entrepreneurial, fast-
paced, small company environment.
· Flexible, independent and self-motivated.
· Strong, strategic, analytical and critical thinking skills.
· Excellent oral and written communication skills, very comfortable assertively managing external vendors while continually demonstrating high levels of interpersonal versatility within diverse populations.
· Ability to build and maintain relationships and establish credibility appropriately.
· Ability to prioritize, organize, plan, and successfully execute and lead multiple tasks and priorities simultaneously.
· An unwavering commitment to the highest quality of work, research ethics and willingness to learn.
Contact:
Please send your CV and cover letter outlining your motivation and relevant experience for the role to [email protected] quoting “35Pharma PostingAPM0723” in the subject line – we are looking forward to hearing from you!
Job Types: Full-time, Permanent
Benefits:
- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Vision care
- Wellness program
Schedule:
Formation:
- Baccalauréat (Obligatoire)
Expérience:
- biotech/pharma/CRO: 3 ans (Obligatoire)
Work Location: In person
