MetaFilter Jobs posts tagged with clinical

Biostatistician - Diagnostics

sevenyearlurk — Fri, 16 May 2008 06:34:56 -0800

We have an exciting opportunity for an experienced biostatistics professional to work from home carrying out advanced multivariate statistical analyses for a cutting-edge molecular diagnostics company. You will be working with clinical biomarker data, developing predictive methods which will help to advance health care research. You should have advanced experience with multivariate statistical methods, including supervised and unsupervised algorithms such as support vector machines and neural networks, and robust cross-validation models. Some experience with statistics for clinical trials (power & bias calculations) would be valuable. The ideal candidate will have 10-15 years of experience in an FDA/Health Canada or health diagnostics technology environment. Advanced education (MSc/PhD) in statistics is preferred but BSc. candidates with substantial industry experience will be considered. This is a Canadian company but because it is work-from-home, US candidates are also invited to apply. We welcome applications from self-employed and incorporated consultants.

Project Manager - clinical applications support

sevenyearlurk — Mon, 14 Jan 2008 07:55:55 -0800

My client is a partner to the pharmaceutical industry, providing electronic data capture applications (eCRFs) for clinical registries (Wikipedia) As a Project Manager, you will be responsible for direct, daily management of one or more clinical registry projects, working closely with other members of the project team. Your role will involve logistics and coordination of various aspects of the project, including obtaining site status reports, developing timelines and task lists for team members and clients, coordination and implementation of client, training, and Advisory Board meetings, and communication with internal stakeholders regarding upcoming deadlines. You will manage project-related Help Desk issues, and will develop and manage cost estimates, budget tracking, monthly billing activities, and project expenses and time entries. Breakdown is approximately 40% project management, 30% applications support, 20% timeline and financial management, and 10% administrative support. The successful candidate will have 3 years of project management experience related to clinical or laboratory applications, and excellent computer and communications skills. Experience in event planning and proficiency with Gantt charts would be an asset.

Clinical Project Manager

sevenyearlurk — Thu, 30 Aug 2007 11:32:10 -0800

My client is a respected biopharmaceutical company focused on small-molecule therapeutics for cancer and autoimmune disorders, located in Cambridge, Massachusetts. We are seeking a Clinical Project Manager to oversee and track the progress of site identification, start-up, monitoring and study completion activities. The role will include the management of CROs and/or contract CRAs and other clinical vendors. You will help develop clinical protocols and documentation, manage study budgets, plan timelines and ensure that deliverables are achieved and deadlines are met. You'll oversee and review CRA performance and work effectively with the rest of the clinical team. The successful applicant will have 5-10 years of progressive experience in clinical operations, with at least 2 years of site monitoring (CRA) experience as well as trial management experience. Specific experience with clinical trials in oncology would be valuable. You should have excellent communications and organizational skills and the ability to understand and manage the "big picture" of global registration trials (principally phases II and III). Good interpersonal and project management skills are a must, and thorough knowledge of ICH-GCP guidelines and FDA regulations pertaining to the drug development process is required. This role may require some travel (25%). Applicants should have at least a bachelor's degree in a relevant field of study; an advanced degree would be an asset.

Clinical Research Associates

sevenyearlurk — Tue, 26 Jun 2007 08:46:39 -0800

I am recruiting for several opportunities with the clinical operations group of an innovative biotechnology company in the greater Boston area. Both in-house and home-based regional monitors are needed to assist with a phase III clinical trial of the company's lead product. Minimum requirements would include: - BS or BA degree in health sciences or life sciences - Solid knowledge of ICH GCP regulations - a minimum of 2 years of clinical monitoring experience in a pharmaceutical/biotech industry or CRO environment - experience with adverse event reporting Experience with Phase III clinical trials involving dermatology products would be an advantage, and a nursing background would be an asset. You must have the ability to communicate and interact within a clinical research environment, be self-motivated with a positive attitude and be able to work effectively under pressure. Flexibility of working hours is required and depending on the role, travel within the US and internationally may be required.