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Clinical Operations Manager - San Diego, United States - ADARx Pharmaceuticals Inc.
Description
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Full Time
Manager
San Diego, CA, US
30 days ago
Requisition ID: 1004
Salary Range:
$105,000.00 To 130,000.00 Annually
Company:
ADARx Pharmaceuticals, Inc., located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics.
ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system diseases.
We are well-financed by a syndicate of renowned VC firms.ADARx currently has multiple active programs in development. Our lead candidate is at the clinical stage.
About the Job:
ADARx is looking for a Clinical Operations Manager, a key member of the clinical team who will manage clinical operations and execution of Company's clinical studies efficiently to agreed corporate timelines and follow local and global requirements.
Responsibilities and Duties:
Manages study operational plans and CRO activities to ensure coordinated execution and quality of study deliverables
Acts as primary liaison to CRO's and vendors for assigned clinical studies/programs
Manages study activities and reports study metrics
Collaborates with other ADARx teams and consultants to successfully coordinate assigned clinical studies
Represents Clinical Operations in cross-functional activities
Contributes to relevant study documentation including clinical protocols, clinical study reports as well as operational plans
Assists in the process of identifying potential vendors, reviewing proposals contributing to the selection process
Proactively identifies and resolves project risks
Develops, forecasts and monitors study related budgets and contracts
Monitors the maintenance of the clinical trial master files.
Assists in the preparation of training materials, SOPs and presentations related to the planning and conduct of the trial
Manages adherence to ICH/GCP/local regulations internally and across sites and vendors
Travels as required development partners, CRO's, vendors, and clinical sites, as needed
Qualifications:
BS, BA in life science or equivalent
Minimum 6-7 years of experience pharmaceutical industry or clinical research site-based experience
Minimum 4 years of experience in managing Phase 1-3 global clinical trials
Strong knowledge of FDA regulations and GCP/ICH guidelines, and knowledge of regulatory requirements regarding clinical trial management
Strong experience in CRO and vendor management to support global clinical trials
Demonstrated skills in writing and reviewing clinical study protocols, CRF, ICF and study documentation development, regulatory documents
Ability to work independently and prioritize and work with a matrix team environment is essential
Operate collaboratively with colleagues across functional areas in a science-driven environment
Team-oriented with excellent verbal and written communication and interpersonal skills
Demonstrated ability to meet short-term deadlines and multi-task in a fast-paced work environment
Ability to travel domestically and internationally (up to 10%)
Compensation:
This is a full-time position, occasional overtime
Pay commensurate with experience
401k with company match
Employee Assistance Program, Employee Discounts
Performance based bonuses
PTO and Holidays
Work Authorization:
United States (Required)
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
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