Clinical Subject Matter Expert
New
P
PharmaviseConsulting Corp.Pharmaceutical, Biotechnology
United StatesContractSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 5 years of experience in clinical research and development
- Required Skills
- GCP
Requirements
- Advanced degree in medicine (MD) or equivalent.
- Board certification or specialization in a relevant therapeutic area preferred.
- Minimum of 5 years of experience in clinical research and development within the pharmaceutical or biotechnology industry, CRO, or academic research setting.
- In-depth understanding of clinical trial design, execution, and regulatory requirements, including GCP guidelines and ICH E6(R2).
- Proven track record of successful clinical trial management and oversight, including experience with Phase I-IV trials.
- Strong analytical and problem-solving skills, with the ability to critically evaluate clinical data and scientific literature.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
- Leadership experience and the ability to influence and inspire cross-functional teams to achieve common objectives.
- Regulatory affairs certification (RAC) or relevant professional certification (e.g., CCRA, CPI) preferred.
Responsibilities
- Serve as the primary clinical expert within the organization, providing guidance and support across clinical development programs.
- Review and interpret clinical trial protocols, study designs, and clinical development plans to ensure scientific rigor and compliance with regulatory requirements.
- Provide strategic input and guidance on clinical trial design, including patient selection criteria, endpoints, and study conduct.
- Monitor ongoing clinical trials for protocol adherence, patient safety, and data integrity, and identify opportunities for optimization and risk mitigation.
- Analyze and interpret clinical trial data, including safety and efficacy outcomes, and provide insights to support decision-making and regulatory submissions.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, medical affairs, and biostatistics, to drive successful execution of clinical programs.
- Stay abreast of emerging scientific advancements, clinical trial methodologies, and regulatory requirements in the field of clinical research.
- Represent the organization externally as a clinical expert, including participation in scientific conferences, regulatory meetings, and interactions with key opinion leaders.
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