Part-time Data Manager
1 day ago
**Position Type**: Part-time
**Department**: PerCuro Clinical Trials
**Work Location**: Victoria, BC
**Work Hours**: 8:00 am - 4:00 pm
**Work Arrangement**: On-site
A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in-house creative agency, and experienced, cross-functional teams. Our core capabilities include **Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services as well as HCP & Clinic Services.**
**Come and join our team But first, let us tell you why we love working here**:
- We are 100% Canadian with locations across the country
- State-of-the-art facilities to provide high-quality products and services
- The opportunity to be a part of a winning, high-performing team
- Collaborative, engaging workplace culture - we are passionate about our people
- Flexible working environment that promotes a healthy work-life balance
- Diverse and inclusive culture where your talent and commitment to excellence is welcomed and valued
- High-growth environment that provides opportunities for learning and growth supported by our Employee Development Program and industry-leading, in-house corporate training offered throughout the year
**The Opportunity**:
The Data Manager and Regulatory Specialist plays a key role in supporting PerCuro by overseeing regulatory submissions, ethics board communications, and study documentation to ensure compliance with institutional and sponsor requirements. This role manages data and regulatory trackers, maintains training and credential records, and coordinates logistics for study operations, drug, and equipment management. Additionally, the specialist ensures accurate safety reporting and supports administrative tasks to facilitate efficient study conduct and documentation integrity.
**A Day in the Life (What you will do here)**:
**Regulatory & Ethics Submissions**
- Revise and manage informed consent forms (ICFs)
- Coordinate with Sponsors/CROs to resolve REB-related issues
- File and share submission/approval documents with relevant stakeholders
- Maintain and update REB trackers
**Study Documentation & Compliance**
- Prepare, scan, and file regulatory documents during start-up and throughout the study
- Maintain Investigator Site Files (ISF) and source documents
- Manage protocol deviations and safety submissions
- Prepare and update SOPs; distribute training logs for review
- Ensure proper archiving of study documents and trackers
**Training & Credentials Management**
- Request and track updated training certifications (e.g., GCP, IATA)
- Maintain and archive CVs, medical and nursing licenses
- Update central and archive training binders
**Study Operations & Logistics**
- Set up and maintain study trackers from contract execution through study visits
- Order and manage lab kits and shipping supplies
- Prepare lab kits weekly and manage inventory (including pulling expired kits)
**Drug & Equipment Management**
- Receive and log drug shipments; confirm receipt in IRT system
- Maintain master drug logs for receipt, dispensing, and returns
- Schedule and document equipment calibration; update related trackers
- Manage temperature excursions and monitor replacements/calibrations
**Safety & Reporting**
- Download, save, and distribute safety reports to Principal Investigators
- Prepare monthly safety trackers and ensure signed copies are filed
- Notify sponsors of any temperature excursions affecting investigational products
**Specialized Tracker Management**
- Maintain IBD and Hepatology trackers for approved SAs, prescriptions, and program-specific data
- Generate and send weekly/quarterly reports as requested
- Add billing items to internal systems and reconcile data
**Administrative Support**
- Respond to study-related queries
- Enter visit data and maintain accurate records
- Verify dry ice invoices and update kit usage trackers
- Assist with other duties as assigned by the manager
**What you need to ensure you are set up for success**:
**Preferred Qualifications**:
- 2-3 years of experience in clinical research, regulatory affairs, or data management, preferably within Canadian healthcare.
- Working knowledge of Health Canada regulations
- Experience preparing and submitting research documents, amendments, renewals, and reports.
- Proficiency in Good Clinical Practice (GCP)
- Strong organizational and communication skills, with the ability to manage multiple studies and coordinate with sponsors, CROs, and internal teams.
- Familiarity with Canadian privacy le
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