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Clinical Trial Legal Specialist
2 months ago
Entrusted Advisors is on the lookout for a skilled healthcare attorney with a robust background in the pharmaceutical sector, specifically in managing intricate contracts related to Clinical Research Organizations (CROs), Clinical Trial Agreements (CTAs), and pharmaceutical supply chains.
Key Responsibilities
- Ensure adherence to all relevant legal standards, regulations, and ethical practices governing clinical trials, including compliance with FDA regulations and ICH-GCP guidelines.
- Oversee and facilitate the negotiation of clinical trial agreements, engaging with CROs, sponsors, clinical sites, and other involved parties.
- Identify potential legal challenges in clinical trials and provide strategic guidance to mitigate risks effectively.
- Draft, review, and negotiate various legal documents, such as informed consent forms, confidentiality agreements, and indemnification clauses.
- Collaborate with regulatory teams to ensure that submissions to regulatory bodies are comprehensive and compliant.
- Act as a liaison between internal and external stakeholders, including sponsors and CROs, to ensure seamless trial execution.
Qualifications
- Juris Doctor (JD) degree from an accredited institution.
- A minimum of 5 years of experience in clinical trial law, with a strong focus on contract negotiations involving CROs, regulatory frameworks, distribution, supply, and payer agreements.
- In-depth knowledge of clinical trial operations, FDA regulations, ICH-GCP guidelines, and other pertinent regulatory standards.
- Exceptional negotiation and communication capabilities.
- Proven ability to manage multiple projects efficiently and meet established deadlines.
- Strong analytical and problem-solving skills, with a keen attention to detail.
- Excellent organizational skills.
Preferred Qualifications
- Experience within a pharmaceutical or biotechnology organization.
Work Environment
- Location: Remote
Entrusted Advisors is a certified women-owned legal services firm. Our attorneys collaborate closely with corporate legal departments, playing a vital role in advancing business objectives. We prioritize building strong relationships to ensure that professionals are placed in roles that align with their career aspirations and provide meaningful challenges.