Clinical Trial Manager I

5 months ago

Mississauga, Canada AstraZeneca Full time

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world.

**This is what you will do**:

- Support the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handle centralized business process tasks, e.g., CDA generation, submission of insurance documentation, safety letter tracking, CSR appendix generation, patient safety cards procurement to support the study. Lead all Safety Reports in TMF and Investigator portal systems, including QC, distribution and tracking.

**You will **be responsible for**:

- Ensuring clinical study document compliance and submission to the TMF throughout the study’s life cycle.
- Ensuring that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
- Serving as a content manager for study-specific internal work spaces.
- Procuring, printing and distributing patient safety cards in multiple languages for use across studies.
- Serving as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure.
- Coordinate delivery of documents to support registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study.
- Act as central point of contact for vendor providing this service.
- Entering, tracking and routing contracts for legal input and approval using business systems and internal work spaces.
- Providing administrative support around and assembly of presentations for Investigator, CRO/vendor kick-off meetings as required.
- May attend cross functional meetings for initiatives in conjunction with the Center of Excellence.

**You will need to have**:

- 2 years of clinical research experience or course-work equivalent in clinical research.
- Strong verbal, written, and organizational skills with a team-oriented approach and the ability to prioritize multiple tasks to meet deadlines in a dynamic environment.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

**We would **prefer** for you to have**:

- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development
- Research certification desirable

**Why Join Us?**

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

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