Clinical Subject Matter Expert
contractโขMaple Grove
About this role
This is a remote position.
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com
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.
Qualifications:
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 but not required.
This is a pivotal role within our organization, offering the opportunity to shape and drive clinical development programs across multiple therapeutic areas. Competitive compensation packages are available.
Be part of our network of Subject Matter Experts.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact [email protected].
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
What you'll do
- Serve as the primary clinical expert within the organization, providing guidance across clinical development programs. Monitor ongoing clinical trials for protocol adherence and patient safety while collaborating with cross-functional teams.
About Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
๐๐ฏ๐ผ๐๐ ๐๐ ๐๐ป๐ณ๐ผ๐ฟ๐บ๐ฎ๐๐ถ๐ผ๐ป:
We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra ๐๐๐๐๐๐๐๐๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐๐๐๐๐๐. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, ๐๐๐๐๐๐ ๐๐๐๐๐๐๐ ๐๐ง๐ ๐๐๐๐๐๐
๐๐๐ ๐๐๐๐๐๐. ๐๐ ๐๐๐ฅ๐ข๐ฏ๐๐ซ ๐๐จ๐ญ๐ก.
๐๐ข๐๐๐๐ซ๐๐ง๐ญ๐ข๐๐ญ๐จ๐ซ๐ฌ:
โ๐๐ข๐ ๐ก๐ฅ๐ฒ ๐๐ค๐ข๐ฅ๐ฅ๐๐ ๐๐๐๐ฆ: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our clientโs success.
โ๐๐ฉ๐๐๐ข๐๐ฅ๐ข๐ณ๐๐ ๐๐ฑ๐ฉ๐๐ซ๐ญ๐ข๐ฌ๐: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.
โ๐๐ฎ๐ฌ๐ญ๐จ๐ฆ๐ข๐ณ๐๐ ๐๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.
๐ฃ๐ฒ๐ฟ๐ณ๐ผ๐ฟ๐บ๐ฎ๐ป๐ฐ๐ฒ ๐๐ถ๐๐๐ผ๐ฟ๐
Over 20 Technical Transfers and 30 product launches.
11 FDA remediations. Warning Letters and or Consent Decrees.
Cost savings and increased efficiency of over 10MM for clients
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Frequently Asked Questions
What does a Clinical Subject Matter Expert do at Pharmavise Corporation?
As a Clinical Subject Matter Expert at Pharmavise Corporation, you will: serve as the primary clinical expert within the organization, providing guidance across clinical development programs. Monitor ongoing clinical trials for protocol adherence and patient safety while collaborating with cross-functional teams..
Is the Clinical Subject Matter Expert position at Pharmavise Corporation remote?
The Clinical Subject Matter Expert position at Pharmavise Corporation is based in Maple Grove, Minnesota, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the Clinical Subject Matter Expert position at Pharmavise Corporation?
You can apply for the Clinical Subject Matter Expert position at Pharmavise Corporation directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.