Senior/Contracts and Budget Associate

Precision Medicine Group (New York, United States); United States; Remote; USD 85,000 - 120,000; Full time

Job summary

Precision for Medicine is seeking a Senior/Contracts and Budget Associate to review, draft, negotiate, and track a variety of legal agreements including confidentiality disclosures, clinical trial agreements, amendments, and site budgets.

The role involves leading interactions with North American and European study teams, sites, and sponsors to ensure timely negotiation and execution while maintaining contract standards and document control.

Qualifications

• 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 (e.g., NDA, CTA) and managing the contract process.
• Experience in contract research, life science, biotech or pharmaceutical industry is preferred.

Responsibilities

• Prepare and negotiate Agreements/Amendments such as CDAs, CTAs and Amendments (CTA-A), vendor contracts and site budgets.
• Lead interactions with North American and European internal study teams and with Sites and Sponsors.
• Resolve contractual issues with supervisor and internal/external stakeholders while ensuring adherence to policies and contracting standards.
• Update study team members and sponsors on contract status and execution; coordinate execution of agreements.

Education

Bachelor’s degree or equivalent

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 clinicalresearch 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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