Job Description

35Pharma

is a clinical-stage biopharmaceutical company focused on developing best-in-class transforming growth factor-beta (TGF-beta) superfamily ligand traps for pulmonary hypertension, obesity and cardiometabolic diseases. 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 Vice-President, Clinical Operations, the

Manager, Study Start-Up

will be responsible to establish and drive the global site selection and activation strategy and provide operational leadership for start-up 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

Manager, Study Start-Up

will provide leadership and mentorship to Clinical Operations team members involved in the activities related to the planification, organization, documentation, tracking, and management of site selection and activation activities, including study and site feasibility, regulatory submissions, site budget and contracting, and collection of sites essential documents.

Main responsibilities:

Accountable for timely start-up activities from country selection until site activation. Organize, manage, and lead site selection and activation activities to ensure project timelines are met. Establish, review, and report on 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. Ensures all documentation is in place for initial and subsequent investigational product (IP) release. Set-up and manage clinical vendors involved in site activation process (i.e., central Institutional Review Board (IRB), translation, investigator site file (ISF) binder). Accountable for timelines, accuracy, and quality of the country and site trial master file (TMF) documents in study start-up to ensure TMF inspection readiness. Review, prepare, and negotiate site contracts and budget with sites. Assist Clinical Operations team 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 and identify external tools/systems used for site selection. Perform country and site feasibility assessment. Contribute to the 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 10 years of experience in a pharmaceutical, biotechnology company, or a contract research organization (CRO), including 5 years in a leadership role for site selection and activation for clinical trials in a CRO. 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. 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.
Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting

"35Pharma Posting

SSU1105"

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
Work Location: Hybrid remote in Montreal, QC H2Y 2Z4