Trial Master File Specialist
4 weeks ago
**35Phama **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.
You will benefit from working closely with an experienced, energetic, and highly motivated team with a successful track record in developing medicines. Our beautiful facilities in Montreal’s Old Port complete with office and laboratory space will be your new workplace.
**Role**:
Reporting to the Senior Director, Clinical Operations, the **Trial Master File Specialist** is responsible for all aspects of the trial master file (TMF) management operations to ensure study documents are collected, reviewed, processed, filed, and archived in compliance with International Council for Harmonisation (ICH): Guideline for Good Clinical Practice (GCP), applicable regulations, and 35Pharma Inc. standard operating procedures (SOP)/policies/work instructions.
The TMF Specialist may also provide support to the clinical operations team in the execution of other project activities, as applicable.
**Key Responsibilities**:
- Process study documents in accordance with 35Pharma Inc. SOPs/policies/work instructions, study requirements, and applicable regulations, including, but not limited to: study documents receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to contract research organizations (CROs)/sites/study teams, and archiving.
- Maintain TMF management action items and decisions logs.
- Track and escalate issues related to study documents and the TMF in a timely manner to ensure quick resolution.
- Distribute information related to the TMF to internal team members and external stakeholders (CROs, vendors, sites).
- Maintain various tracking and reporting tools related to management of the TMF.
- Establish and maintain TMF status reports and performance metrics to ensure TMF health and inspection readiness.
- Communicate directly with the CROs, clinical research associates, sites and other internal team members to ensure all documents required for the TMF are collected, reviewed, and filed appropriately in a timely manner.
- Act as primary point of contact for 35Pharma Inc. with TMF system vendor.
- May prepare/review/update clinical study plans or other TMF management related documents or trackers (i.e., TMF plan, TMF checklists, ISF checklists, etc.).
- May support any clinical and regulatory operations project activities as deemed necessary to ensure the clinical program success. This may include for example support for the creation/maintenance of an investigators database, support in the review of clinical trial agreements and site budgets, tracking of site payments and verification of site payment requests against visits and procedures completed in the electronic case report form (eCRF).
**Qualifications**:
- Minimum of bachelor’s degree in health sciences or related degree within life sciences.
- Minimum of 2 years’ experience in TMF document management activities in a pharmaceutical or biotechnology company, or a CRO.
- Proven experience with various electronic TMF systems (i.e., VeevaVault, TransPerfect, Agatha Clinical, etc.)
- Strong knowledge of clinical study documents and sites essential documents.
- Creative, independent and self-motivated.
- Good oral and written communication skills.
- Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.
- An unwavering commitment to the highest quality of work, research ethics and willingness to learn.
- Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other clinical systems (i.e., electronic data capture (EDC), eTMF, Quality Management System (QMS)) and computer skills.
**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**:
**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:
- Monday to Friday
**Education**:
- Bachelor's Degree (required)
**Experience**:
- Trial Master File document management activities: 2 years (requir
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