Associate Director of Clinical Operations
Piper Health & Sciences is seeking an Associate Director of Clinical Operations to oversee and manage clinical operations activities, with a focus on government contracts at the National Institutes of Health (NIH) across various therapeutic areas, including infectious disease, oncology, and drug abuse.
The ideal candidate must have a strong background in site monitoring subject matter expertise, extensive experience in client-facing roles within Contract Research Organizations (CROs), and a proven track record in managing large-scale clinical projects.
This role is located in the greater Washington DC area and requires a minimum of 2-3 days of on-site work.
Responsibilities for the Associate Director of Clinical Operations include:
oManage and oversee clinical project management, clinical site management, and/or clinical study management activities.
oEnsure adherence to regulatory guidelines (FDA requirements, GCPs/ICH guidelines), data management/analysis, and scientific/technical writing processes.
oProvide subject matter expertise in site monitoring, essential regulatory document collection/review, and study start-up activities.
oTake responsibility for one or more complex drug development programs, ensuring that deliverables are achieved within budget and well-defined timelines.
oIdentify potential risks and implement risk management/mitigation strategies to maintain project progress.
oSupport and comply with the company's Quality Management System policies and procedures.
oDrive project and company performance improvement solutions, including corrective and preventive actions (CAPA) as required.
oContribute to the development of standard operating procedures (SOPs) and proposals for government and commercial clients.
oParticipate in proposal writing, budget development, and bid defense meetings, as needed.
Qualifications for the Associate Director of Clinical Operations include:
oDirect experience at a CRO is required.
oBroad multidisciplinary understanding of pharmaceutical clinical research and development processes.
oBackground in Infectious Disease/HIV clinical trials and/or Oncology is highly desirable.
oExperience in the conduct of Phase 1 protocols or prior work on a government contract is a plus.
oHands-on experience in regulatory affairs, clinical operations, or clinical trial monitoring/management.
oStrong facilitation, presentation, problem-solving, and conflict resolution skills.
oExtensive experience in managing large-scale projects and programs.
oProficiency in the use and development of clinical research databases/systems/tools.
oExpertise in Microsoft Word, PowerPoint, and Excel; experience with Microsoft Project is preferred.
Compensation for the Associate Director of Clinical Operations includes:
oSalary range:
approximately $155,000 - $175,000 annually, commensurate with experienceoFull
Benefits:
Medical, Dental, Vision, 401k, PTO, Hybrid FlexibilityKeywordsClin ops, clinical operations, clinical research, clinical trials, infectious disease, oncology, cancer, regulatory, reg affairs, clinical research organization, cro, phase 1, early phase Recommended Skills Clinical Research Clinical Trials Clinical Works Conflict Resolution Data Management Databases Estimated Salary: $20 to $28 per hour based on qualifications.
The ideal candidate must have a strong background in site monitoring subject matter expertise, extensive experience in client-facing roles within Contract Research Organizations (CROs), and a proven track record in managing large-scale clinical projects.
This role is located in the greater Washington DC area and requires a minimum of 2-3 days of on-site work.
Responsibilities for the Associate Director of Clinical Operations include:
oManage and oversee clinical project management, clinical site management, and/or clinical study management activities.
oEnsure adherence to regulatory guidelines (FDA requirements, GCPs/ICH guidelines), data management/analysis, and scientific/technical writing processes.
oProvide subject matter expertise in site monitoring, essential regulatory document collection/review, and study start-up activities.
oTake responsibility for one or more complex drug development programs, ensuring that deliverables are achieved within budget and well-defined timelines.
oIdentify potential risks and implement risk management/mitigation strategies to maintain project progress.
oSupport and comply with the company's Quality Management System policies and procedures.
oDrive project and company performance improvement solutions, including corrective and preventive actions (CAPA) as required.
oContribute to the development of standard operating procedures (SOPs) and proposals for government and commercial clients.
oParticipate in proposal writing, budget development, and bid defense meetings, as needed.
Qualifications for the Associate Director of Clinical Operations include:
oDirect experience at a CRO is required.
oBroad multidisciplinary understanding of pharmaceutical clinical research and development processes.
oBackground in Infectious Disease/HIV clinical trials and/or Oncology is highly desirable.
oExperience in the conduct of Phase 1 protocols or prior work on a government contract is a plus.
oHands-on experience in regulatory affairs, clinical operations, or clinical trial monitoring/management.
oStrong facilitation, presentation, problem-solving, and conflict resolution skills.
oExtensive experience in managing large-scale projects and programs.
oProficiency in the use and development of clinical research databases/systems/tools.
oExpertise in Microsoft Word, PowerPoint, and Excel; experience with Microsoft Project is preferred.
Compensation for the Associate Director of Clinical Operations includes:
oSalary range:
approximately $155,000 - $175,000 annually, commensurate with experienceoFull
Benefits:
Medical, Dental, Vision, 401k, PTO, Hybrid FlexibilityKeywordsClin ops, clinical operations, clinical research, clinical trials, infectious disease, oncology, cancer, regulatory, reg affairs, clinical research organization, cro, phase 1, early phase Recommended Skills Clinical Research Clinical Trials Clinical Works Conflict Resolution Data Management Databases Estimated Salary: $20 to $28 per hour based on qualifications.
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