Clinical Affairs Director will lead and manage the Clinical Affairs Department globally, reporting to the VP of R&D.
PhD Molecular Biology/Biochemistry with 7 years clinical research experience, or MS with 10 years clinical research experience
Clinical trials management experience leading to successful 510(k) and/or PMA submissions
Minimum of 10 years’ experience in a GMP and/or FDA regulated environment
3 years International clinical trials experience
The Clinical Affairs Director will lead and manage a department globally. The main focus is the clinical validation of new in vitro diagnostic products. Will collaborate with Research, Regulatory, Scientific Affairs,and Sales & Marketing departments. Will ensure that the conduct of clinical research studies are in accordance with regulations and standards (e.g. 21 CFR part 812, CLSI, ICH, etc). Will also be responsible for the department’s administrative duties and the preparation and monitoring of the departmental fiscal year budget. Reports to the VP, R&D. Travel may be 20% of the time; International travel may be 10% of the time. Position may be at the office in TX or the upper Midwest.
Personality Profiling: STEM Professionals in the New Economy
STEM Professionals need a range of skills to succeed in the new economy. Learn what key characteristics employers are looking for in technical hires.
ASQ Inland Empire Sections 706 and 711 will be profiling the STEM professional for the new economy that will be presented by our very own Rosemarie Christopher.
In this day and age, companies are being more selective as far as educational background, social media reputation, personality profiling and skills testing, subsequently making it harder for those that are looking to be hired land a job.
What makes you a GREAT performer in the new economy
Interpersonal traits that make you the power team leader at work
Understanding your personality profile to advance your career
Her presentation will go over these issues, and help you explore your strengths and weaknesses in the workforce to help you better prepare for entering the workforce and landing that job, keeping it, and moving forward in your professional career.
ASQ Chapter 711 Meeting
22069 Van Buren Street
Grand Terrace, CA 92313 (map)
01/20/2016 @ 7:15pm PST
ASQ Chapter 706 Meeting
Ali Baba Persian Restaurant
17513 Chatsworth St.
Granada Hills, CA 91344 (map)
02/16/16 @ 5:30pm PST
Clinical Studies Manager plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials.
Minimum MS/PhD in Molecular Biology, Biochemistry or related discipline with at least 3 years’ related experience in clinical trials OR
Minimum BA/BS degree in Molecular Biology, Biochemistry or related discipline with at least 6 years’ related experience in clinical trials
Required Work Experience:
Training & work experience in document and record management for clinical study (GCP)
Must have good understanding of 21 CFR Part 812 regulations and CLSI guidelines
Experience in a GMP and/or FDA regulated environment
Experience working independently in a fast-paced environment with rapidly changing priorities, as well as working well in a team-oriented environment
Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Strong organizational skills and exceptional time management and prioritization skills
Excellent verbal and written communication skills
Must work onsite
Travel may be required, including approximately 10% International travel
Clinical Studies Manager KeyResponsibilities
This position is responsible for managing clinical study activities. The position plays a major role in coordinating clinical studies, from qualification of clinical study sites through monitoring of clinical study activities and completion of clinical trials. The position helps to ensure that clinical studies are executed in compliance to applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH). The position also involves writing of study protocols, reports, SOPs and other documents.
Manage the planning and execution of clinical studies
Play a leading role in the qualification of clinical trial sites
Coordinate collection and tracking of clinical study specimens
Participate in clinical site training, monitoring, and support
Play a role in the analysis and interpretation of clinical trial data
Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements
Prepare clinical study final reports
Monitor adherence to protocols during clinical studies and determine study completion
Participate in project core teams by presenting clinical study status updates and data
Manage clinical trial resources and timelines in coordination with project core teams
Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for in vitro diagnostic devices
Conform to applicable regulations and standards and company quality policies
Medical Device Compliance Auditor for Boston or Minneapolis Area
Medical Device Quality and Regulatory Compliance professionals needed for two opportunities to assess non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management
Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485)
The Division of Apprenticeship Standards (DAS) creates opportunities for Californians to gain employable lifetime skills and provides employers with a highly skilled and experienced workforce while strengthening California’s economy. MEIRxRS apprenticeship program supports this mission by requiring apprentices to work toward an industry certification while they are enrolled in the apprentice program. Each certification requires a mix of training and experiential learnings. Apprentices are paired with mentors who can provide guidance and support for the duration of the one to two year apprenticeship.
Our apprentices can be deployed in any FDA-regulated industry (food, biotech, pharmaceutical, medical device, nutraceutical, and cosmeceutical). Our grants cover the cost of training and mentoring the apprentice. If a mentor is not available within the host company, MEIRxRS will identify one.