Algorithme Pharma, an Altasciences company, is an internationally recognized Contract Research Organization (CRO). We conduct over 200 clinical trials annually in Phase I/IIa, Bioequivalence and Bioanalysis with the participation of over 5,000 participants. In other words, we conduct trials for new drugs or new combinations of drugs, new devices, or new ways to use existing treatments. Our team is made up of close to 500 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of pharmaceutical science.
We are currently looking for a Senior Clinical Research Scientist to join our team. Want to contribute to research activities? Do you have rapid execution, while bringing attention to detail? This position is for you! Send us your resume immediately.
The Senior Clinical Research Scientist is responsible for gathering and synthesizing scientific information for the purpose of providing high-quality scientific documentation to support sponsors' research programs for investigational drugs, biologicals, or medical devices. He also provides scientific support to the other company divisions and acts as a scientific consultant with the clients. The Senior Clinical Research Scientist will lead and support the design, execution, scientific support and reporting of clinical trials, mainly with pharmacokinetic endpoints.
- Develop and maintain expert knowledge, providing consultative support as needed;
- Ensures that all related work and procedures are conducted in compliance with SOPs and relevant regulations;
- Perform quality control review of analysis/documents prepared by other scientists;
- Perform literature, clinical and non-clinical data searches/reviews as necessary to obtain background information for development of documents;
- Responsible for authoring or contributing to development of clinical and regulatory documents (study design, study protocols, statistical analysis plans, clinical study reports), as needed, for various study designs such as bioavailability/bioequivalence studies, food-effect, and, and other complex clinical projects;
- Perform non-compartmental pharmacokinetic analyses using WinNonlin, as needed;
- Coordinates internal protocol review;
- Review and provide feedback on client-provided protocols;
- Work closely with team members in Project Management to handle client comments;
- Actively participate in internal project team meetings/lessons learned meetings, as required; participates in client meetings as necessary;
- Be aware of all needs and guidelines to ensure that documents are in compliance with applicable regulatory guidelines, SOPs, and goals of submission;
- Maintain familiarity with client expectations and produce documents consistent with these;
- Present details of workshops/courses attended or new knowledge acquired. Provide in-house training courses as required;
- Provide assistance to answer agencies queries (deficiency letters);
- Development of formats, templates and general guidelines for documentation procedures;
- Support the growth and development of less experienced departmental members by providing technical training and guidance;
- Perform other tasks appropriate to a more senior position as required;
- Update drug database;
- Undertake continuous learning and development on regulations, pharmacology, physiology, therapeutics, and acute and chronic diseases through self-training, workshops and conferences;
- Prioritize own work and manage project schedule to meet delivery deadlines;
- Preparation and presentation of scientific posters, articles and abstracts;
- Aware of regulatory guidelines of related authorities (TPD, FDA, EMA) as well as GCP and GLP procedures;
- Participate in committees, task force groups as needed;
- Development of training plans;
- Initiate and participate in departmental or interdepartmental quality improvement initiatives;
- Maintain and participate in the objectives of the unit and recognizes cost reduction opportunities;
- Assist in the development of unit SOPs;
- Represents Algorithme Pharma in scientific meetings/exhibitions or business meetings;
- Other related tasks.
- Bachelor s degree in Pharmacy, Pharmacology or other related discipline, higher level is an asset;
- Minimum 5 years experience in a related position with similar level of responsibility;
- Experience in clinical pharmacology, pharmacokinetics, and pharmacodynamics as well as with Clinical Trial writing (Clinical Study Reports and Protocols) in a contract research organization, pharmaceutical or biotechnology firm;
- Experience in other fields like clinical research, statistics and analytical development is an asset;
- Flexible attitude with respect to work assignments and new learning;
- Excellent communication skills (written and verbal in French & English);
- Excellent customer service skills;
- Excellent organizational skills, sense of urgency and analytical skills;
- Excellent understanding of clinical research, drug development process, and applicable regulatory guidelines;
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail;
- Ability to interpret and organize scientific data;
- Ability to work with a multi-disciplinary team of professionals;
- Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various IT systems.
We offer comprehensive training to all our employees, a dynamic work environment that fosters teamwork and above all, a job where you can develop your career.
By providing your application to Algorithme Pharma, an Altasciences Company, you hereby consent to Algorithme Pharma obtaining personal information that is related to the position for which you applied. You also consent to Algorithme Pharma transferring your application details to our recruitment partners for their review and assistance. You also consent to Algorithme Pharma keeping your application on file. Algorithme Pharma is an equal opportunity employer referring to the Employment Equity Act of Canada. The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.
If your application meets the qualifications of this position, a member of the Human Resources department will call you. Please note that only candidates selected for an interview will be contacted.
Please send your CV by email: