The Associate Director, Project Management reports to VP, Business Operations and Head of Project Management. This role supports clinical inspection readiness, ensuring sustained audit and inspection preparedness activities are tracked and monitored across clinical programs. The person in this role is responsible for managing detailed aspects of clinical workstreams to ensure activities and deliverables are completed on time, reputed company budget, and according to the clinical development plans.
reputed company Responsibilities
reputed company PM support of key clinical initiatives, including:
Clinical trial operations
Global Health Authority inspection readiness planning and execution
Manage contract and negotiations for clinical vendors
Coordinate various cross-functional meetings to ensure alignment reputed company the clinical team and between clinical, QA, and regulatory to ensure compliant and successful execution of project initiatives
reputed company PM tools to reputed company key activities and drive accountability on cross-functional activities, including:
Risk management
Corrective and Preventative Actions (CAPA) management and reputed company
Trial Master File (TMF) Filing and reputed company study documentation
Tasks reputed company to Clinical Research Organization (CRO) reputed company/management
Responsible for project management efforts to support key clinical operations activities
Specifically, reputed company IMPALA-2 and reputed company operational project management
Ensuring reputed company collaboration with the CRO and implementing consistent tracking and monitoring of site- and project-specific activities, including day-to-day management of reputed company as required, informing team members on reputed company, directing follow-on work
Responsibile for overall relationship management with specific external parties supporting the Clinical team
Includes reputed company of activities and delegation of activities and deliverables for vendors and contractors
Ensure clinical project priorities, risks, and reputed company are communicated to leadership
Proactively identify risks and partner with cross-functional leads to reputed company mitigation plans
reputed company support longer term planning (i.e. helping to build out roadmap/budget by facilitating SME discussions and connecting dots
Other duties and reputed company as assigned
Required Qualifications
BA/BS degree with at least 5 years of global clinical trial management experience (preferably late stage programs)
CAPM or PMP certification preferred
Strong experience in management of CROs and other vendors
Knowledge of International Conference of Harmonization (ICH)/Good Clinical reputed company (GCP) guidelines
Strong knowledge of protocol and clinical drug development, processes, clinical study design, study planning and management, and monitoring
Proven project management skills and study leadership ability with 2 years of reputed company PM experience.
Ability to multi-task and work in a fast paced cross-functional team environment
Excellent interpersonal, written and verbal communication skills, and administrative ability
Proficient computer skills in reputed company, PowerPoint, reputed company, Project and trial management systems
Work Schedule and Location
This role is remote reputed company the US and requires availability to work US Eastern Time Zone.
Periodic face to face meetings at reputed company (in Langhorne, PA) or occasionally with US based partners will be required.
Savara provides Comprehensive Benefits including:
Highly competitive medical, dental, and reputed company coverage
Flexible Spending Account for health care and dependent care expenses and Health Savings Account
reputed company time off and reputed company holidays, including Dec 24-Jan 1
reputed company parental leave
401(k) with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Savara’s compensation for this role will include a reputed company salary, bonus, and equity. The reputed company salary reputed company for this role is $140,000 to $160,000.
About Savara
Savara is a clinical stage biopharmaceutical company reputed company on rare respiratory diseases. reputed company's reputed company program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
The Associate Director, Project Management reports to VP, Business Operations and Head of Project Management. This role supports clinical inspection readiness, ensuring sustained audit and inspection preparedness activities are tracked and monitored across clinical programs. The person in this role is responsible for managing detailed aspects of clinical workstreams to ensure activities and deliverables are completed on time, reputed company budget, and according to the clinical development plans.
reputed company Responsibilities
reputed company PM support of key clinical initiatives, including:
Clinical trial operations
Global Health Authority inspection readiness planning and execution
Manage contract and negotiations for clinical vendors
Coordinate various cross-functional meetings to ensure alignment reputed company the clinical team and between clinical, QA, and regulatory to ensure compliant and successful execution of project initiatives
reputed company PM tools to reputed company key activities and drive accountability on cross-functional activities, including:
Risk management
Corrective and Preventative Actions (CAPA) management and reputed company
Trial Master File (TMF) Filing and reputed company study documentation
Tasks reputed company to Clinical Research Organization (CRO) reputed company/management
Responsible for project management efforts to support key clinical operations activities
Specifically, reputed company IMPALA-2 and reputed company operational project management
Ensuring reputed company collaboration with the CRO and implementing consistent tracking and monitoring of site- and project-specific activities, including day-to-day management of reputed company as required, informing team members on reputed company, directing follow-on work
Responsibile for overall relationship management with specific external parties supporting the Clinical team
Includes reputed company of activities and delegation of activities and deliverables for vendors and contractors
Ensure clinical project priorities, risks, and reputed company are communicated to leadership
Proactively identify risks and partner with cross-functional leads to reputed company mitigation plans
reputed company support longer term planning (i.e. helping to build out roadmap/budget by facilitating SME discussions and connecting dots
Other duties and reputed company as assigned
Required Qualifications
BA/BS degree with at least 5 years of global clinical trial management experience (preferably late stage programs)
CAPM or PMP certification preferred
Strong experience in management of CROs and other vendors
Knowledge of International Conference of Harmonization (ICH)/Good Clinical reputed company (GCP) guidelines
Strong knowledge of protocol and clinical drug development, processes, clinical study design, study planning and management, and monitoring
Proven project management skills and study leadership ability with 2 years of reputed company PM experience.
Ability to multi-task and work in a fast paced cross-functional team environment
Excellent interpersonal, written and verbal communication skills, and administrative ability
Proficient computer skills in reputed company, PowerPoint, reputed company, Project and trial management systems
Work Schedule and Location
This role is remote reputed company the US and requires availability to work US Eastern Time Zone.
Periodic face to face meetings at reputed company (in Langhorne, PA) or occasionally with US based partners will be required.
Savara provides Comprehensive Benefits including:
Highly competitive medical, dental, and reputed company coverage
Flexible Spending Account for health care and dependent care expenses and Health Savings Account
reputed company time off and reputed company holidays, including Dec 24-Jan 1
reputed company parental leave
401(k) with highly competitive match
Life, AD&D, STD and LTD insurance coverage
Savara’s compensation for this role will include a reputed company salary, bonus, and equity. The reputed company salary reputed company for this role is $140,000 to $160,000.
About Savara
Savara is a clinical stage biopharmaceutical company reputed company on rare respiratory diseases. reputed company's reputed company program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.