Senior Clinical Data Manager (Contractor) ABOUT THE POSITION: The Senior Clinical Data Manager is responsible for Clinical Data Management (CDM) support for clinical studies following Standard Operating Procedures (SOP) and Guidelines. The person in this position should work as the lead clinical data manager for clinical trials and works closely with the lead clinician and biostatistician to develop the data management plan and electronic Case Report Forms (eCRF), build the Electronic Data Caption (EDC) system, author and program the Edit Check specifications, lead and guide the UAT of the EDC system, cooperate with lead EDC validation personal, lead data review, generate and solve data queries, create operational data sets, reconcile external data sets and safety data sets, perform database lock activities. ESSENTIAL DUTIES AND KEY DELIVERABLES: Participate in planning and support of clinical studies. Implement CDISC/CDASH standards in CDM. Prepare eCRFs and lead the...
Jul 04, 2020
Senior Clinical Data Manager (Contractor) ABOUT THE POSITION: The Senior Clinical Data Manager is responsible for Clinical Data Management (CDM) support for clinical studies following Standard Operating Procedures (SOP) and Guidelines. The person in this position should work as the lead clinical data manager for clinical trials and works closely with the lead clinician and biostatistician to develop the data management plan and electronic Case Report Forms (eCRF), build the Electronic Data Caption (EDC) system, author and program the Edit Check specifications, lead and guide the UAT of the EDC system, cooperate with lead EDC validation personal, lead data review, generate and solve data queries, create operational data sets, reconcile external data sets and safety data sets, perform database lock activities. ESSENTIAL DUTIES AND KEY DELIVERABLES: Participate in planning and support of clinical studies. Implement CDISC/CDASH standards in CDM. Prepare eCRFs and lead the...
MacOS Developer We are seeking an experienced and versatile MacOS Developer to assist in the development of an installation & hardware integration tool and to provide operational and process-related analysis and support. 3+ year experience in a similar role Comprehensive knowledge of C++ and Objective C. Swift, Perl, Python is a plus Expert knowledge of MacOS system services, including Foundation, Darwin, BSD Experience with UIKit and basic user interface paradigms Work closely with stakeholders to determine solutions, assess impact to existing work processes and systems, and pinpoint how to manage integration Ability to understand technical requirements,...
Jul 04, 2020
MacOS Developer We are seeking an experienced and versatile MacOS Developer to assist in the development of an installation & hardware integration tool and to provide operational and process-related analysis and support. 3+ year experience in a similar role Comprehensive knowledge of C++ and Objective C. Swift, Perl, Python is a plus Expert knowledge of MacOS system services, including Foundation, Darwin, BSD Experience with UIKit and basic user interface paradigms Work closely with stakeholders to determine solutions, assess impact to existing work processes and systems, and pinpoint how to manage integration Ability to understand technical requirements,...
Manager Quality Assurance PRIMARY PURPOSE OF POSITION: This position is responsible for GMP Quality Assurance . Responsibilities would include support of key quality systems (clinical and commercial), product release, developing and reporting metrics, annual product reviews, auditing, and ensuring company and third-party contractors comply with global and U.S. regulations and standards. MAJOR DUTIES OF POSITION: Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Develops and maintains compliant GMP Quality Management Systems, programs, policies, specifications, methods, and procedures to ensure product quality conforms to established standards and agency guidelines. Performs batch record reviews and timely release of clinical and commercial products. Work cross functionally and with CMOs to ensure timely closure Quality records including Deviations, CAPAs, Complaints, and Change Controls. Partners with Supply...
Jul 04, 2020
Manager Quality Assurance PRIMARY PURPOSE OF POSITION: This position is responsible for GMP Quality Assurance . Responsibilities would include support of key quality systems (clinical and commercial), product release, developing and reporting metrics, annual product reviews, auditing, and ensuring company and third-party contractors comply with global and U.S. regulations and standards. MAJOR DUTIES OF POSITION: Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Develops and maintains compliant GMP Quality Management Systems, programs, policies, specifications, methods, and procedures to ensure product quality conforms to established standards and agency guidelines. Performs batch record reviews and timely release of clinical and commercial products. Work cross functionally and with CMOs to ensure timely closure Quality records including Deviations, CAPAs, Complaints, and Change Controls. Partners with Supply...
DescriptionThe Registered Nurse is a clinical practitioner who coordinates and implements patient care specific to the age of the patient population Associated topics: adult nurse practioner, anesthetist, arnp, assistant cna, certified nursing assistant, clinical nurse, nurse specialist, ob, prn, specialist
Jul 04, 2020
DescriptionThe Registered Nurse is a clinical practitioner who coordinates and implements patient care specific to the age of the patient population Associated topics: adult nurse practioner, anesthetist, arnp, assistant cna, certified nursing assistant, clinical nurse, nurse specialist, ob, prn, specialist
Warehouse Team Member ( Seasonal, Part-Time, Reduced Time, Flexible Hours ) Shifts: Overnight, Early morning, Day, Evening, Weekend Location 455 Valley Drive, Brisbane, CA 94005. Take public transportation to work. Find out more details at a hiring event. Salary : Earn $17.25/hr Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Job Description AMAZON FRESH WAREHOUSES We offer fresh, frozen, and packaged groceries, so you ll work in varying climates from room temperature to freezer environments. We will provide you with the right gear to stay warm during the colder parts of your shift. If you need flexibility in your schedule, this job allows you to choose from available shifts each week to create your own. * Flexible hours, a reliable pay rate, and no surprises! Apply now. Start as soon as 7 days. No resume or previous work experience required. Candidates...
Jul 04, 2020
Warehouse Team Member ( Seasonal, Part-Time, Reduced Time, Flexible Hours ) Shifts: Overnight, Early morning, Day, Evening, Weekend Location 455 Valley Drive, Brisbane, CA 94005. Take public transportation to work. Find out more details at a hiring event. Salary : Earn $17.25/hr Amazon remains open as an essential business to serve our communities delivering critical supplies directly to the doorsteps of people who need them. Job Description AMAZON FRESH WAREHOUSES We offer fresh, frozen, and packaged groceries, so you ll work in varying climates from room temperature to freezer environments. We will provide you with the right gear to stay warm during the colder parts of your shift. If you need flexibility in your schedule, this job allows you to choose from available shifts each week to create your own. * Flexible hours, a reliable pay rate, and no surprises! Apply now. Start as soon as 7 days. No resume or previous work experience required. Candidates...
Nomad Health, the modern healthcare staffing company, seeks an experienced registered nurse for this rewarding travel assignment opportunity. Join Nomad's growing team of registered nursing professionals. Nomad offers nurses a hassle-free experience, industry-leading pay rates, full benefits, and exceptional service. Earn more. Stress less. Be a Nomad! Start Date: 2020-7-13 QUALIFICATIONS Active Registered Nurse license in the specified state. RN degree from an accredited registered nurse program. BLS and all relevant specialty/department-specific certifications required. Two years of RN experience and 1 year of recent experience in the specialty. NOMAD BENEFITS Housing: Stipend provided. Best-in-class availability through our housing partner. Travel: Up to $1,000 reimbursement for travel to your assignment. Medical/Dental: Major medical and dental plans available from your first day of work. Payroll: Weekly deposits direct to...
Jul 03, 2020
Nomad Health, the modern healthcare staffing company, seeks an experienced registered nurse for this rewarding travel assignment opportunity. Join Nomad's growing team of registered nursing professionals. Nomad offers nurses a hassle-free experience, industry-leading pay rates, full benefits, and exceptional service. Earn more. Stress less. Be a Nomad! Start Date: 2020-7-13 QUALIFICATIONS Active Registered Nurse license in the specified state. RN degree from an accredited registered nurse program. BLS and all relevant specialty/department-specific certifications required. Two years of RN experience and 1 year of recent experience in the specialty. NOMAD BENEFITS Housing: Stipend provided. Best-in-class availability through our housing partner. Travel: Up to $1,000 reimbursement for travel to your assignment. Medical/Dental: Major medical and dental plans available from your first day of work. Payroll: Weekly deposits direct to...
Document Control/Quality Assurance ABOUT THE POSITION: This primary purpose of this position is to perform data entry, file documents, and assist with training binder completion for the Quality Assurance team.. This positon will report to the Associate Director, Quality Assurance. ESSENTIAL DUTIES AND KEY DELIVERABLES: Organizes paper and electronic Quality documents. Performs data entry, primarily in Excel. Reviews and ensures completion of training binders. Assists in assigning training curriculum for employees. Distributes monthly system-generated training compliance reports. Participates in Quality Compliance department meetings. Prepares, distributes and posts meeting agendas/minutes, and related materials. QUALIFICATIONS: High School Graduate, Associates Degree Preferred Superior organizational skills. Excellent attention to detail. Proficiency in Microsoft Excel and Word Why Kelly? As a worker today, it s up to you to take...
Jul 02, 2020
Document Control/Quality Assurance ABOUT THE POSITION: This primary purpose of this position is to perform data entry, file documents, and assist with training binder completion for the Quality Assurance team.. This positon will report to the Associate Director, Quality Assurance. ESSENTIAL DUTIES AND KEY DELIVERABLES: Organizes paper and electronic Quality documents. Performs data entry, primarily in Excel. Reviews and ensures completion of training binders. Assists in assigning training curriculum for employees. Distributes monthly system-generated training compliance reports. Participates in Quality Compliance department meetings. Prepares, distributes and posts meeting agendas/minutes, and related materials. QUALIFICATIONS: High School Graduate, Associates Degree Preferred Superior organizational skills. Excellent attention to detail. Proficiency in Microsoft Excel and Word Why Kelly? As a worker today, it s up to you to take...
Quality Assurance Manager Good Clinical Practices (contract or contract to hire) PRIMARY PURPOSE OF POSITION This primary purpose of this position will be responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP preferred experience not mandatory) oversight and for assuring the quality and compliance of Clinical Development projects, products and programs. Work in collaborations with Clinical Department and other functional areas as needed on the implementation of the Quality Management System to achieve a high level of quality and compliance to regulated activities, company standards and expectations of regulatory authorities. JOB DESCRIPTION Implement and maintain the Quality System in the areas of GCP and GPvP, in accordance with the local and global requirements. Develop quality metrics for GCP and GPvP in collaboration with Clinical Operations, Data Management, and Drug Safety. Prepare periodic reports based on metrics and quality...
Jul 02, 2020
Quality Assurance Manager Good Clinical Practices (contract or contract to hire) PRIMARY PURPOSE OF POSITION This primary purpose of this position will be responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP preferred experience not mandatory) oversight and for assuring the quality and compliance of Clinical Development projects, products and programs. Work in collaborations with Clinical Department and other functional areas as needed on the implementation of the Quality Management System to achieve a high level of quality and compliance to regulated activities, company standards and expectations of regulatory authorities. JOB DESCRIPTION Implement and maintain the Quality System in the areas of GCP and GPvP, in accordance with the local and global requirements. Develop quality metrics for GCP and GPvP in collaboration with Clinical Operations, Data Management, and Drug Safety. Prepare periodic reports based on metrics and quality...
Kelly IT Resources is looking for Project Manager for a long-term project located in Emeryville. This role has a strong potential in converting to a permanent employee. MAJOR DUTIES OF POSITION: Lead cross-functional project teams that deliver Sales & Marketing IT solutions including Customer Relationship Management (CRM), Marketing Automation, Data Warehouse, Data Integration, Business Intelligence and Analytics. Provide functional and technical subject matter expertise in the pharmaceutical product commercialization processes and technology landscape. Assist in analyzing business requirements and contribute to IT strategy/ roadmap to meet the business requirements. Take responsibility for all aspects of a project including managing selected vendors timelines and service levels. Ensure that project documentation and deliverables are created/ updated in accordance to Santen Systems Development Lifecycle process and Santen Project Management Methodology. Author...
Jul 02, 2020
Kelly IT Resources is looking for Project Manager for a long-term project located in Emeryville. This role has a strong potential in converting to a permanent employee. MAJOR DUTIES OF POSITION: Lead cross-functional project teams that deliver Sales & Marketing IT solutions including Customer Relationship Management (CRM), Marketing Automation, Data Warehouse, Data Integration, Business Intelligence and Analytics. Provide functional and technical subject matter expertise in the pharmaceutical product commercialization processes and technology landscape. Assist in analyzing business requirements and contribute to IT strategy/ roadmap to meet the business requirements. Take responsibility for all aspects of a project including managing selected vendors timelines and service levels. Ensure that project documentation and deliverables are created/ updated in accordance to Santen Systems Development Lifecycle process and Santen Project Management Methodology. Author...
PRIMARY PURPOSE OF POSITION: This position is responsible for GCP systems and functions at Santen Inc. Responsibilities include Quality Assurance oversight of Clinical Operations and ensuring third party and Santen Inc. operations comply with global and U.S. regulations and are in an inspection ready status. This position also supports global quality and system initiatives. In addition of GCP activities, this position supports GVP activities related to QA. MAJOR DUTIES OF POSITION: Performs a wide variety of activities to ensure global compliance with applicable global regulatory requirements Arranges global GCP auditing schedule and calendar, balances workload, and arranges contract audit support when needed Leads/coordinates internal and external GCP compliance audits on a continuing basis to ensure integrity of documentation and clinical data. Ensures global internal and clinical site and service provider compliance with current regulations. Interacts with Contract...
Jul 02, 2020
PRIMARY PURPOSE OF POSITION: This position is responsible for GCP systems and functions at Santen Inc. Responsibilities include Quality Assurance oversight of Clinical Operations and ensuring third party and Santen Inc. operations comply with global and U.S. regulations and are in an inspection ready status. This position also supports global quality and system initiatives. In addition of GCP activities, this position supports GVP activities related to QA. MAJOR DUTIES OF POSITION: Performs a wide variety of activities to ensure global compliance with applicable global regulatory requirements Arranges global GCP auditing schedule and calendar, balances workload, and arranges contract audit support when needed Leads/coordinates internal and external GCP compliance audits on a continuing basis to ensure integrity of documentation and clinical data. Ensures global internal and clinical site and service provider compliance with current regulations. Interacts with Contract...
Nomad Health, the modern healthcare staffing company, seeks an experienced registered nurse for this rewarding travel assignment opportunity. Join Nomad's growing team of registered nursing professionals. Nomad offers nurses a hassle-free experience, industry-leading pay rates, full benefits, and exceptional service. Earn more. Stress less. Be a Nomad! Start Date: Immediate Start QUALIFICATIONS Active Registered Nurse license in the specified state. RN degree from an accredited registered nurse program. BLS and all relevant specialty/department-specific certifications required. Two years of RN experience and 1 year of recent experience in the specialty. NOMAD BENEFITS Housing: Stipend provided. Best-in-class availability through our housing partner. Travel: Up to $1,000 reimbursement for travel to your assignment. Medical/Dental: Major medical and dental plans available from your first day of work. Payroll: Weekly deposits...
Jul 02, 2020
Nomad Health, the modern healthcare staffing company, seeks an experienced registered nurse for this rewarding travel assignment opportunity. Join Nomad's growing team of registered nursing professionals. Nomad offers nurses a hassle-free experience, industry-leading pay rates, full benefits, and exceptional service. Earn more. Stress less. Be a Nomad! Start Date: Immediate Start QUALIFICATIONS Active Registered Nurse license in the specified state. RN degree from an accredited registered nurse program. BLS and all relevant specialty/department-specific certifications required. Two years of RN experience and 1 year of recent experience in the specialty. NOMAD BENEFITS Housing: Stipend provided. Best-in-class availability through our housing partner. Travel: Up to $1,000 reimbursement for travel to your assignment. Medical/Dental: Major medical and dental plans available from your first day of work. Payroll: Weekly deposits...