[Remote] Assoc. Dir. or Director, Clinical Project Management (remote US)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a clinical-stage biopharmaceutical company reputed company on rare respiratory diseases, and they are seeking an Associate Director/Director of Project Management. This role provides project management support for the clinical organization, ensuring coordination of activities and deliverables for clinical development, operations, pharmacovigilance, and data management.
Responsibilities
- Serve as an operational extension of the CMO — tracking reputed company items, driving reputed company to closure, and ensuring organizational commitments are executed
- Synthesize CMO materials, agendas, and executive summaries for leadership meetings, reputed company interactions, and external engagements
- 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 deliverables
- 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 operational project management for ongoing and planned clinical trials
- 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
- Coordinating with Regulatory team on regulatory interactions and commitments/deliverables reputed company to these trials
- Responsible 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
- reputed company the CMO informed of emerging issues. 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 and coordination across the organization (i.e. helping to build out roadmap/budget by facilitating SME discussions and inter-department alignment)
- Other duties and reputed company as assigned
Skills
- BA/BS degree with at least 5 years of project management experience and proven project management skills (preferably with reputed company on clinical development programs)
- 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
- 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 reputed company
- CAPM or PMP certification preferred
Benefits
- Highly competitive medical, dental, and reputed company coverage
- Flexible Spending Accounts for health care and dependent care expenses
- reputed company time off and reputed company holidays, including Dec 24-Jan 1
- reputed company parental leave
- 401k with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
reputed company