This is a full-time employment opportunity onsite in montreal, qc, canada.
**as a manager, biostatistics you will:
- implement project-specific strategies and assist with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.
- assist with the oversight of statistical operations personnel. This includes hiring personnel, managing personnel matters, conducting performance evaluations, and training statisticians regarding applicable regulatory guidelines and statistical practices.
- participate in interactions with regulatory agencies and assist with resource allocation and the development of business proposals related to the biostatistics and programming department.
- be responsible for the statistical aspects of projects for clients and project teams through management of internal staff. Provide input into crf and dvs development in all therapeutic areas (e.G. Edit checks for clinical trial data).
- serve as the statistical lead on projects when appropriate and develop a close liaison with the client contacts, sas programmers, biostatisticians, and project managers to drive the statistical aspects of project delivery.
- and more!
**required education and experience**
- phd in statistics, biostatistics, or related field with some applied statistics training relevant to the clinical trials or health research environment and with 3 years of relevant work experience or a master’s degree in statistics, biostatistics, or a related field and 5 to 7 years of biostatistical experience in the clinical trials or health research environment.
- thorough knowledge of ich gcp guidelines and other applicable regulatory rules and guidelines and of medical terminology, clinical trials, and clinical research.
- working knowledge of the relationship and regulatory obligation of the cro industry with pharmaceutical/biotech companies.
**about our client**
join a team that works on groundbreaking compounds and profoundly impacts patients’ lives! they are serious about scientific integrity and has a dynamic company culture, including a focus on work-life balance.
**value proposition for you**
- flexible work schedule.
- proven potential for professional growth.
- a community of brilliant minds at your disposal.
- the stability of working for a robust, financially sound cro that is growing at a sustainable pace.
- exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.
Note: please attach your latest cv along with your response on zintro.+34 Other Responses
Hi. This is a question for an expert in nurse informatics. I was wondering do you think computers are an important component of your career? If so, in what ways are they needed and beneficial to what it is you do?+2 Other Responses
This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area.
-responsible for coordinating and monitoring the day-to-day logistics of our clinical trials.
-manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
-manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
-ensure the progress and completion of projects according to timelines
-prepare and present project specific updates
-lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
-monitor safety surveillance and reporting activities
-oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
-coordinate dsmb/safety reviews inline with charter and overall study parameters
-assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures
-plan, generate, and track study timelines and trial budgets
-site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites
-ba/bs degree in biological science or nursing required (equivalent experience may be accepted)
-5+ years of clinical research in the biotechnology/pharmaceutical industry
-3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials
-experience managing cros, central laboratories, and other clinical study vendors
-experience preparing clinical trial budgets and contracts
-knowledge of ich-gcps and 21 cfr is required
-experience in metabolic/hepatic drug development is desirable
-experience with ivrs and/or edc is desirable+24 Other Responses
Clinical Trial Investigation
I'm looking to talk to clinical trial principal investigators, medical researchers who have run or are running clinical trials, about their experiences.+54 Other Responses