Senior Clinical Research Manager

Senior Clinical Research Manager Personalized Stem Cells, Inc Poway, CA Job Details Full-time $85,000•$100,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Qualifications Medical writing Computer operation Clinical study protocols and reports Procedural guides Word processing Regulatory compliance Contract research organization experience Bachelor's degree Clinical training Quality control Clinical trials Clinical trial standard operating procedures Productivity software Data collection Clinical trial support in drug product development Standard operating procedures (SOPs) Healthcare research FDA regulations Senior leadership Time management

Full Job Description Job Summary:

Personalized Stem Cells, Inc. conducts human cell therapy development including clinical trial operations. This Senior Manager is responsible for all aspects of the organization and conduct of the human clinical research operations. These operations include the planning, execution, and oversight of clinical research studies conducted internally and those conducted by a contract

CRO. PSC

will be conducting a significant number of Phase I/II clinical studies in US-based medical clinics under approved FDA INDs. These studies will assess the safety and efficacy of patient-derived stem cell products (autologous) as well as donor-derived (allogeneic) cell products for orthopedic and other medical conditions. We are seeking a senior experienced clinical research professional to manage this department and these studies in compliance with FDA rules and guidelines. This will be a small group and manager must be very hands on.

Responsibilities:

The primary focus of this position is on the management of this department and monitoring of study related activities. The candidate will need to develop systems and processes to assure the efficient and smooth operation of clinical research studies. For smaller phase 1 studies, the study monitoring with be both remote (main office) and on-site at each investigational site. The Senior Manager will be expected participate in hands-on operations as well as oversight on one or more Clinical Research staff in performing site initiation/training, study monitoring, data collection and quality control, and study close-out, including on-site visits. The Senior Manager will be expected to serve as a resource and liaison between research staff, clinical sites and PSC internal resources such as QA, Manufacturing, Regulatory and Medical Director. Senior Manager will be the leader of the clinical research department and responsible for the timely and accurate execution of the clinical trial protocols. Candidate will be responsible for creation of department and study budgets and adhering to these budgets. As company progresses, Manager will assume role of oversight of the CRO contractors. Knowledge, Skills, and Abilities Required BA/BS in a science or health related field or Nursing Degree. At least 5 years previous clinical study experience Excellent organizational and communication skills Computer proficiency, including the use of standard software (Word, Excel, databases, e-mail) and the use of Internet. Experience with EDC software a real plus. Time management skills and problem-solving abilities Excellent writing skills (Protocols, forms, instructions, SOPs, WIs) Ability to work with doctors and medical site personnel Excellent critical thinking skills including ability to rapidly adapt and learn Strong experience working in an FDA regulated clinical trial environment

Job Type:

Full-time Location:

Poway CA (Required)•

NO COMMUTE TO LA JOLLA / SORRENTO

Benefits:

Health with vision and dental, 401k with match Small company environment with flexibility for family issues

Salary Range:

$85,000•$110,000 depending on experience. www.

PersonalizedStemCells.com

Pay:

$85,000.00•$100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical study: 5 years (Required)

Location:

Poway, CA 92064 (Required)

Work Location:

In person