Senior Clinical Trial Manager
Angitia Biopharmaceuticals, Los Angeles, CA, United States
Position:
Senior Clinical Trial Manager
Department:
Development
Location:
Remote with up to 25% travel
Reports To:
Director of Clinical Operations
Position Summary
The Senior Clinical Trial Manager will be responsible for the management of one or more clinical trials including management of both the cross-functional internal team as well as vendors to ensure Angitia clinical trials are executed efficiently, on time, within budget and in compliance with SOPs, applicable regulations, and ICH/GCP guidelines.
Responsibilities
Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met and that deliverables are completed on time and within budget.
Oversee the identification, selection, on-boarding, and management of study vendors including CROs, central /specialty labs, and imaging vendors etc.
Main point of contact for Full-service CRO, including all sub-contracted activities.
Provide study-specific training and direction/oversight to vendor personnel to ensure study delivery per the scope of work and key performance indicators.
Oversee and partner with external and internal stakeholders to ensure clinical trial data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise 'quality assured'.
Contribute to clinical operations deliverables by providing updates (e.g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs).
Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring), and ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations.
Timely review and approval of invoices, monthly accruals, and forecast budget variances.
Review and approve monitoring reports per monitoring plan and elevate as needed.
Track key study activities using tracking tools.
Identify issues and risks and propose potential resolutions.
Qualifications
BS/BA (or equivalent) in a relevant scientific discipline; advanced degree desirable.
6+ years of relevant industry experience in clinical drug development (at least 3 years of CRA experience, 2 years of study management experience).
Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
Strong experience in management of CROs and other vendors.
Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Experience leading global clinical research activities, both early and late development experience preferred.
Exceptional project management, cross-functional team leadership, and critical thinking and organizational skills.
Excellent interpersonal, written and verbal communication skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Management.
Effective team player and ability to influence and collaborate with cross functional clinical study teams.
Strong leadership skills, self-motivated, adaptable to a dynamic environment.
Ability to make decisions, set priorities, and share resources to benefit the whole organization.
Strong analytical skills with a data driven approach to planning, implementing, and problem solving.
Salary Range:
$130,000 - $160,000
Benefits
Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement
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Senior Clinical Trial Manager
Department:
Development
Location:
Remote with up to 25% travel
Reports To:
Director of Clinical Operations
Position Summary
The Senior Clinical Trial Manager will be responsible for the management of one or more clinical trials including management of both the cross-functional internal team as well as vendors to ensure Angitia clinical trials are executed efficiently, on time, within budget and in compliance with SOPs, applicable regulations, and ICH/GCP guidelines.
Responsibilities
Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met and that deliverables are completed on time and within budget.
Oversee the identification, selection, on-boarding, and management of study vendors including CROs, central /specialty labs, and imaging vendors etc.
Main point of contact for Full-service CRO, including all sub-contracted activities.
Provide study-specific training and direction/oversight to vendor personnel to ensure study delivery per the scope of work and key performance indicators.
Oversee and partner with external and internal stakeholders to ensure clinical trial data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise 'quality assured'.
Contribute to clinical operations deliverables by providing updates (e.g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs).
Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring), and ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations.
Timely review and approval of invoices, monthly accruals, and forecast budget variances.
Review and approve monitoring reports per monitoring plan and elevate as needed.
Track key study activities using tracking tools.
Identify issues and risks and propose potential resolutions.
Qualifications
BS/BA (or equivalent) in a relevant scientific discipline; advanced degree desirable.
6+ years of relevant industry experience in clinical drug development (at least 3 years of CRA experience, 2 years of study management experience).
Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
Strong experience in management of CROs and other vendors.
Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Experience leading global clinical research activities, both early and late development experience preferred.
Exceptional project management, cross-functional team leadership, and critical thinking and organizational skills.
Excellent interpersonal, written and verbal communication skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Management.
Effective team player and ability to influence and collaborate with cross functional clinical study teams.
Strong leadership skills, self-motivated, adaptable to a dynamic environment.
Ability to make decisions, set priorities, and share resources to benefit the whole organization.
Strong analytical skills with a data driven approach to planning, implementing, and problem solving.
Salary Range:
$130,000 - $160,000
Benefits
Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement
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