Polaris Pharmaceuticals Inc.
Clinical Trial Manager/Associate Manager
Polaris Pharmaceuticals Inc. - San Diego, California, United States, 92189
Work at Polaris Pharmaceuticals Inc.
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Overview
Clinical Trial Manager/Associate Manager
Clinical Trial Manager/Associate Manager
Polaris Pharmaceuticals Inc. provided pay range
This range is provided by Polaris Pharmaceuticals Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$105,000.00/yr - $145,000.00/yr Role Title:
Clinical Trial Manager/Associate Manager Reports to:
SVP Clinical Affairs FLSA:
Exempt Salary Range -$105K to $145K CORE VALUES Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company’s lead therapeutic, ADI-PEG 20, is a novel biologic in late stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. ROLE SUMMARY We are seeking a Manager or Associate Manager in Clinical Trials with oncology experience to manage clinical studies with our lead therapeutic agent. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible and willing to take on additional responsibilities as required. ROLE RESPONSIBILITIES : Coordinate and supervise the implementation of clinical studies Prepare project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries Manage clinical monitoring activities and conduct monitoring visit or co-monitoring visits, as required Manage CROs and vendors, as required Monitor and track clinical research progress and provide status update reports Assist in pharmacovigilance activities Maintain the internal Trial Master File and periodically review Act as liaison to clinical sites and provide guidance on site/study issues Manage clinical study budgets Prepare interim/final clinical study reports Contribute to development of SOPs, abstracts, presentations, and manuscripts SKILLS & QUALIFICATIONS : Bachelor’s degree, preferably in science or healthcare Demonstrated clinical research experience in the biotech/medical diagnostics/pharmaceutical industry, CRO or in a hospital setting with experience in oncology Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines Excellent written and verbal communication skills Polaris Pharmaceuticals, Inc. does not discriminate in employment opportunities or practices on the basis of race, color, gender, religion, veteran and military status, marital or registered domestic partner status, age, national origin or ancestry, disability, medical condition (including genetic information or characteristics), sexual orientation, or any other characteristic protected by federal, state, or local laws. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Product Management, Project Management, and Management Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Polaris Pharmaceuticals Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Clinical Trial Manager jobs in
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Clinical Trial Manager/Associate Manager
Polaris Pharmaceuticals Inc. provided pay range
This range is provided by Polaris Pharmaceuticals Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$105,000.00/yr - $145,000.00/yr Role Title:
Clinical Trial Manager/Associate Manager Reports to:
SVP Clinical Affairs FLSA:
Exempt Salary Range -$105K to $145K CORE VALUES Polaris Pharmaceuticals, Inc. is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company’s lead therapeutic, ADI-PEG 20, is a novel biologic in late stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. ROLE SUMMARY We are seeking a Manager or Associate Manager in Clinical Trials with oncology experience to manage clinical studies with our lead therapeutic agent. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible and willing to take on additional responsibilities as required. ROLE RESPONSIBILITIES : Coordinate and supervise the implementation of clinical studies Prepare project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries Manage clinical monitoring activities and conduct monitoring visit or co-monitoring visits, as required Manage CROs and vendors, as required Monitor and track clinical research progress and provide status update reports Assist in pharmacovigilance activities Maintain the internal Trial Master File and periodically review Act as liaison to clinical sites and provide guidance on site/study issues Manage clinical study budgets Prepare interim/final clinical study reports Contribute to development of SOPs, abstracts, presentations, and manuscripts SKILLS & QUALIFICATIONS : Bachelor’s degree, preferably in science or healthcare Demonstrated clinical research experience in the biotech/medical diagnostics/pharmaceutical industry, CRO or in a hospital setting with experience in oncology Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines Excellent written and verbal communication skills Polaris Pharmaceuticals, Inc. does not discriminate in employment opportunities or practices on the basis of race, color, gender, religion, veteran and military status, marital or registered domestic partner status, age, national origin or ancestry, disability, medical condition (including genetic information or characteristics), sexual orientation, or any other characteristic protected by federal, state, or local laws. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Product Management, Project Management, and Management Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Polaris Pharmaceuticals Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Clinical Trial Manager jobs in
San Diego, CA . San Diego County, CA $125,000.00-$150,000.00 7 hours ago Clinical Trial Participant Recruitment Project Manager
Sr. Manager / Manager, Drug Safety (Post Market)
Sr. CTM/Associate Director, Clinical Operations
Associate Director Clinical Trial Materials
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr