Clinical Project Coordinator - Québec, Canada - 35Pharma Inc.

35Pharma Inc.

Verified Company

Québec, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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.

The
Clinical Project Coordinator provides support to the clinical operations team in the execution of all aspects of clinical trial and regulatory operations activities in accordance with ICH/GCPs, applicable regulations, and 35Pharma SOPs/policies.

Key Responsibilities:

Support the clinical operations project team (i.e., Clinical Project Manager, Program Manager) and management team (i.e., Director/Senior Director/VP), in the daytoday management of clinical projects and clinical operations management activities.
Support the clinical operations team in coordinating, preparing, and distributing meeting agendas, meeting minutes, and presentation slides, as appropriate.
Support the clinical operations team in tracking action items and decisions logs. Track and escalate issues (as appropriate) in a timely manner to ensure quick resolution.
Setup, maintain, and ensure completeness of projectspecific training records.
Manage the preparation and distribution of study supplies (ie, investigator study files, study material), as necessary.
Distribute information to internal team members and external stakeholders (Contract Research Organization (CRO), vendors, sites).
Maintain various tracking and reporting tools and systems needed by the clinical operations team.
Collect, track, review, and file all sites essential documents and other required clinical documents in the electronic trial master file (eTMF).
Communicate directly with the CROs, Clinical Research Associates, sites and other internal team members to ensure all documents required for the eTMF are collected and filed in a timely manner.
Assist in the review of Clinical Trial Agreements and site budgets, create tracking tool to capture costs per procedures per site and site payments and verify site payment requests against visits and procedures completed in the eCRF.
May prepare/review/update clinical study plans (i.e., project management plan, communication plan, eTMF plan, study reference manuals, study forms, etc.).
May support 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' experience in clinical drug development and project coordination/management in a pharmaceutical or biotechnology company, or a CRO.
Flexible, independent and selfmotivated.
Excellent 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 (CTMS, EDC, eTMF, QMS) and computer skills.

Perks: