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Full-time
bachelor degree
Posted 5d ago
~40 hrs/week
Remote in South Korea, Taiwan
Responsibilities
The associate will review, draft, and negotiate various legal agreements including clinical trial agreements and site budgets. They will also coordinate with internal study teams and sponsors to ensure contractual deliverables align with project timelines.
Requirements
Candidates must have a bachelor's degree and at least 3 years of relevant experience in contract management within the clinical research or life sciences industry. Proficiency in drafting and negotiating complex legal documents is essential for this role.
Full job description
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Precision for Medicine is looking for a Senior/Contracts and Budget Associate.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations.
Essential functions of the job include but are not limited to: • Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets. • Lead interactions with the North American and European internal study teams, as applicable • Lead interactions regarding the various agreements with the Site(s) • Lead interactions regarding assigned agreements with the Sponsor(s) • Work with supervisor and various internal/external stakeholders to resolve contractual issues. • Ensure adhered to company policies, procedures, and contracting standards. • Update relevant study team members and sponsors regarding the status of contract negotiations and execution. • Coordinate execution of the agreements • Support the maintenance of contract files and databases, including email and document archiving. • Other duties as assigned.
Requirements : • Bachelor’s degree, or equivalent contract management experience preferably in a clinical research or similar industry setting • 3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical research i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process. • Experience in contract research, life science, biotech or pharmaceutical industry is preferred.
Preferred: • Equivalent contract management experience in a clinical research or similar industry setting • Experience in contract research, life science, biotech or pharmaceutical industry.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. We provide end-to-end services for the entire manufacturing lifecycle for pharmaceutical and biotech companies, universities, hospitals, and government agencies. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.
One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
Cleaning Validation Compliance & Quality Assurance Commissioning & Qualification Computer Systems Validation Controls & AutomationEnvironmental MonitoringEngineeringFinancial Strategy Process Validation Program Management
Project Farma is a patient-focused global leader in advancing technical operations from ideation through commercialization with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations for complex biologics and novel modalities. We provide end-to-end services for the entire manufacturing lifecycle for pharmaceutical and biotech companies, universities, hospitals, and government agencies. Project Farma has executed 100+ facility builds, retrofits and expansions, managed 400+ large scale capital projects, industrialized 10+ commercial cell, gene, and novel therapies, and managed $6B+ in technical operations capital investments.
One of our core values is giving back. Volunteering at hospitals, supporting life science related fundraisers and partnering with nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but we also bring our team and our client’s team closer to the actual patients and families that will be impacted by our work.
Project Farma is a PerkinElmer company. (https://www.projectfarma.com/)
Offices: 710 Bridgeport Ave, Shelton, Connecticut 06484, US
Cleaning Validation Compliance & Quality Assurance Commissioning & Qualification Computer Systems Validation Controls & AutomationEnvironmental MonitoringEngineeringFinancial Strategy Process Validation Program Management