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Senior Clincial Trial Manager
- Permanent
- Clinical Trial Assistant (CTA), Project/Study Manager (CSM/CPM), Program Manager / Director
- Canada
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Senior Clinical Trial Manager with a global biopharmaceutical company located in Canada. As the Senior Clinical Trial Manager, you will coordinate and lead the company functional team members, CROs and vendors in the Americas to successfully deliver clinical studies under direction from Regional Director.
Job Responsibilities:
- Oversee study scope, quality, timelines and budget with the internal company functional leads, CRO and vendors to ensure that overall project objectives are met.
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff.
- Partner with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time.
- Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data.
- Proactive identification and management of study related risks.
- Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements.
- Responsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
- Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs.
- Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project.
Skills and Requirements:
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
- 5+ years of clinical project management experience in conducting International clinical trials in Pharma/Biotech organization.
- Prior phase III experience required
- A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process.
- Experience with budget forecasting and management
- Experience with clinical studies in infectious or rare diseases a plus
- Proven proficiency in overseeing large complex studies being managed by a CRO.
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced and enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships.
- Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues.
- Demonstrated ability to build and deliver on patient enrollment strategies.
- Excellent written and oral communication skills.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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