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.
Qualifications:
Minimum Required:
Other Required:
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.
Precision Medicine Group is a diversified organization operating in the clinical research and pharmaceutical marketing sectors. The company includes Precision AQ, a leading payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence by developing marketing strategies and communication programs for healthcare payers. Precision for Medicine is a Contract Research Organization (CRO) specializing in clinical trial management with a focus on oncology and rare diseases, offering clinical research associate services with an emphasis on employee retention and quality of life. The organization's integrated approach combines novel clinical trial designs, operational and medical expertise, advanced biomarker and data analytics solutions, and a commitment to precision medicine and oncology.
