Responsibilities include but are not limited to:
- Ensure the design, implementation and timelines of study deliverables are consistent with study requirements and budget expectations
- Assemble, mentor and lead the clinical trial team and conduct effective team meetings to model good communication practices throughout the trial
- Utilize proven audit techniques to establish a practical approach for maintaining regulatory compliance
- Implement best practices for managing misconduct and fraud to protect patient safety
- Utilize proven quality control tools to collect and measure performance data and participate in or lead process improvement initiatives
- Identify and prioritize financial, technical, and legal risks to ensure project success
- Interact with clients/partners to provide timely project updates, project related fiscal information and ensure correct protocol interpretations
- Develop or assist in developing scientific protocols and protocol amendments
- Provide input for the development of proposals for new work and participate in bid defenses or presentations when required
- Fulfill other cross-functional duties as required
- Minimum undergraduate degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution. Advanced graduate degree preferred.
- Previous project management experience in a related industry that demonstrates problem solving, time management and negotiation skills
- A minimum of five (5) years’ experience in clinical research. Therapeutic experience in respiratory, oncology and cardiovascular indications preferred
- In-depth knowledge of ICH / GCP guidelines and local regulatory regulations regarding drug research and development required
- Excellent organization and English/French communication skills (oral and written), and demonstrated proficiency in Microsoft® Office
- Ability to multitask, set priorities and work independently
- Strong service orientation with exceptional people skillsLocation: Ottawa head office Only qualified applicants will be contacted.
Allphase Clinical Research is a progressive Contract Research Organization (CRO) dedicated to providing quality and service excellence to...