Clinical Trial Manager, HI-Bio
Posted on Sep 25, 2024 by Biogen
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
About This Role
Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases.
This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.
What You’ll Do
Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
Provide operational guidance to sites, CRO and other key suppliers
Provide operational oversight of clinical study suppliers
Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
Attend scientific meetings
Strategize and coordinate efforts to ensure completeness of eTMF
Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
Manage budget, approve invoices and participate in the monthly accrual process
Participate in the testing of clinical study systems including IRT and EDC
Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
Ensure effective, consistent, efficient and compliant processes.
Who You Are
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. For the right candidate we are open to hiring remote-US with a preference for West Coast talent.
About This Role
Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases.
This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.
What You’ll Do
Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
Provide operational guidance to sites, CRO and other key suppliers
Provide operational oversight of clinical study suppliers
Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
Attend scientific meetings
Strategize and coordinate efforts to ensure completeness of eTMF
Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
Manage budget, approve invoices and participate in the monthly accrual process
Participate in the testing of clinical study systems including IRT and EDC
Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
Ensure effective, consistent, efficient and compliant processes.
Who You Are
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. For the right candidate we are open to hiring remote-US with a preference for West Coast talent.
Reference: 202393433
https://jobs.careeraddict.com/post/95558133
Clinical Trial Manager, HI-Bio
Posted on Sep 25, 2024 by Biogen
South San Francisco, CA
Research
Immediate Start
Annual Salary
Full-Time
Job Description
About This Role
Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases.
This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.
What You’ll Do
Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
Provide operational guidance to sites, CRO and other key suppliers
Provide operational oversight of clinical study suppliers
Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
Attend scientific meetings
Strategize and coordinate efforts to ensure completeness of eTMF
Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
Manage budget, approve invoices and participate in the monthly accrual process
Participate in the testing of clinical study systems including IRT and EDC
Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
Ensure effective, consistent, efficient and compliant processes.
Who You Are
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. For the right candidate we are open to hiring remote-US with a preference for West Coast talent.
About This Role
Make the most meaningful impact of your career in this rewarding role with HI-Bio, Inc., a Biogen company. As a Clinical Trial Manager you will design operational strategy and oversee our clinical research organization (CRO) partners to provide operational input into the development of clear protocol concepts and final protocols. You will own or share responsibility for entire clinical trial studies, including operational design, successful delivery, and the positive impact on the lives of patients with a wide array of immune-mediated diseases.
This is a hybrid (part-time on-campus) opportunity, with full-time remote work considered.
What You’ll Do
Independently or in conjunction with other study Clinical Trial Leads, develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
Chair the Clinical Study Team (CST) meeting to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
Provide operational guidance to sites, CRO and other key suppliers
Provide operational oversight of clinical study suppliers
Strategize and coordinate efforts with study start up including site feasibility, site selection, and distribution of regulatory packets
Attend scientific meetings
Strategize and coordinate efforts to ensure completeness of eTMF
Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
Manage budget, approve invoices and participate in the monthly accrual process
Participate in the testing of clinical study systems including IRT and EDC
Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
Ensure effective, consistent, efficient and compliant processes.
Who You Are
Scientifically and clinically astute, you’re a mission-driven individual with the strategic vision to see the big picture and assume responsibilities much broader and more meaningful than day-to-day operations. Decisive, analytical and self-confident, you are determined to own all of your career and the difference you can make on the lives of others through your leadership and ability to inspire excellence.
This position is a Hybrid role requiring travel into our South San Francisco offices on a regular basis. For the right candidate we are open to hiring remote-US with a preference for West Coast talent.
Reference: 202393433
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