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Global Early Clinical Development Manager

Company: SSI
Location: Thousand Oaks
Posted on: March 26, 2020

Job Description:

Please review the job description below and reply me with Your updated word copy resume. Best number and time to reach you for further discussion. Title Global Early Clinical Development Manager - CA location Thousand Oaks, CA or San Francisco , CA Contract ndash 13 Months (Possible of extension) Comments Onsite Thousand Oaks, CA or San Francisco , CA- Please note location on top of resumes when submitting. Ideal Candidate- Phase 1 experience Minimum 5 yearrsquos experience in clinical research management Oncology trial experience Global Trial experience Strong scientific background- academic or experience in clinical research setting. Protocol writing experience- a plus Responsibilities Planning, management and reporting of clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities Identification and resolution of issues Communication of study timelines and deliverables ensuring studies are conducted in accordance with SOPs, GCP and regulatory guidance Contributing to the First in Human Portal documentGlobal Development Plan Contributing toauthoring protocols, relevant sections of annual safety reports, clinical study reports, and publications Management andor oversight of study budget, timelines and insourcingoutsourcing partners to the required standards Preferred Qualifications MS or RN 7+ years of experience in life sciences or medically related field 4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company Management experience of direct reports Experience in oversight of Functional Service Providers, outside vendors (CROrsquos, central labs, imaging vendors, etc) Basic Qualifications Doctorate Degree OR Master's Degree and 3 years of Clinical experience OR Bachelor's Degree and 5 years of Clinical experience OR Associate's degree and 10 years of Clinical experience OR High school diplomaGED and 12 years of Clinical experience Why is the Position Open? Supplement additional workload on team Top 3 Must Have Skill Sets Phase 1 clinical research study management experience. Dose escalationexploration studies. Oncology experience preferred. Day to Day Responsibilities Support and develop the operational strategy of assigned program clinical trials and work cross-functionally to support the delivery of all trial activities. Manage the daily activities of clinical trial conduct. Employee Value Proposition Client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoplersquos lives. A biotechnology pioneer since 1980, Client has grown to be one of the worldrsquos leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential Possible Extension Yes Red Flags NA Interview Process Phone or conference interview

Keywords: SSI, Thousand Oaks , Global Early Clinical Development Manager, Healthcare , Thousand Oaks, California

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