Alpha Clinical
Responsibilities
Provide clinical scientific input to clinical and project teams.
Collaborate with cross-functional teams to design and execute clinical trials (early to late phase).
Develop and optimize clinical trial protocols, investigator brochures, and other regulatory documents.
Partner with biomarker and translational teams, including external experts, to design assessments and integrate results with clinical data.
Analyze and interpret clinical and biomarker data to support trial decisions, publications, and regulatory filings.
Review and summarize data from ongoing trials to ensure quality and integrity.
Set up and manage fully outsourced clinical trials, ensuring compliance with corporate and regulatory standards (clinical conduct, data integrity, drug supply, regulatory submissions, data management, and statistics).
Manage clinical budgets and timelines, ensuring forecasts are met.
Provide accurate, timely reports to senior leadership on trial status and data quality.
May lead the clinical team for a specific asset.
Represent the clinical team in project and client leadership meetings.
Qualifications and Profile
Strong clinical science background; Bachelor’s degree in Biological Sciences, Psychology, Life Sciences, or equivalent experience.
Significant experience in Clinical Operations, including oversight of fully outsourced trials.
Global experience across early and late phase clinical trials.
Proven ability to manage multiple projects and priorities.
Strong working knowledge of GCP/ICH guidelines and conducting studies under IND.
Experience managing internal and external resources.
Extensive knowledge of drug development functions and processes.
Seniority level Mid-Senior level
Employment type Full-time
Location: Boston, MA
Salary: $260,000.00 - $360,000.00
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Provide clinical scientific input to clinical and project teams.
Collaborate with cross-functional teams to design and execute clinical trials (early to late phase).
Develop and optimize clinical trial protocols, investigator brochures, and other regulatory documents.
Partner with biomarker and translational teams, including external experts, to design assessments and integrate results with clinical data.
Analyze and interpret clinical and biomarker data to support trial decisions, publications, and regulatory filings.
Review and summarize data from ongoing trials to ensure quality and integrity.
Set up and manage fully outsourced clinical trials, ensuring compliance with corporate and regulatory standards (clinical conduct, data integrity, drug supply, regulatory submissions, data management, and statistics).
Manage clinical budgets and timelines, ensuring forecasts are met.
Provide accurate, timely reports to senior leadership on trial status and data quality.
May lead the clinical team for a specific asset.
Represent the clinical team in project and client leadership meetings.
Qualifications and Profile
Strong clinical science background; Bachelor’s degree in Biological Sciences, Psychology, Life Sciences, or equivalent experience.
Significant experience in Clinical Operations, including oversight of fully outsourced trials.
Global experience across early and late phase clinical trials.
Proven ability to manage multiple projects and priorities.
Strong working knowledge of GCP/ICH guidelines and conducting studies under IND.
Experience managing internal and external resources.
Extensive knowledge of drug development functions and processes.
Seniority level Mid-Senior level
Employment type Full-time
Location: Boston, MA
Salary: $260,000.00 - $360,000.00
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