About 35Pharma:
35Pharma is a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily therapeutics. 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 Montreal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.
Role:
Reporting to the Senior Director, Clinical Operations, the Site Activation Specialist will be responsible for successful management of all site selection and activation 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 Site Activation Specialist will provide support to the Clinical Project Managers and Associate Project Managers in planning, organizing, documenting, tracking, and managing day to day site selection and activation activities, including site budget and contract and collection of sites essential documents required for site activation.
Main Responsibilities:
- Organize, manage, and track site selection and activation activities to ensure project timelines are met.
- Set-up and maintain site selection and activation performance metrics.
- Liaise with internal functional teams to ensure site selection and activation tasks are completed in compliance with organizational goals, SOPs, quality standards, approved timelines, and within budget.
- Support the preparation, review, and updating of study documents related to site activation such as informed consent forms, feasibility questionnaires, site qualification visit material, etc.
- Support the Clinical Project Managers/Associate Project Managers in the set-up and management of clinical vendors involved in site activation process (i.e., central Institutional Review Board (IRB), translation, investigator site file (ISF) binder).
- Support the TMF Specialist in collection, review, tracking and filing of sites essential documents required for site activation.
- Review, prepare and negotiate site contracts and budget with sites.
- Assist the Clinical Project Managers/Associate Project Managers and Legal department (as applicable) in the negotiation and management of non-disclosure agreement (NDA) and clinical trial agreement (CTA).
- Set-up and maintain investigators database.
- May perform site feasibility assessment and site qualification activities.
- 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 2 years of experience in a pharmaceutical, biotechnology company, or a contract research organization (CRO), in a clinical project coordinator or site activation role in clinical trials.
- Proficiency in required software (Word, Excel, PowerPoint 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.
- 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 careers@35pharma.com quoting “35Pharma Posting SA0402” in the subject line – we are looking forward to hearing from you!
