Clinical Project Manager
- Employer
- Altimmune, Inc.
- Location
- Gaithersburg, Maryland
- Start date
- Sep 23, 2019
View more
- Discipline
- Clinical, Clinical Project Management, Clinical Research, Clinical Trials, Science/R&D, Biology, Chemistry, Research, Laboratory
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Summary of Position:
Clinical Project Manager plays an important part in the clinical trial process. The CPM position will perform a wide variety of activities to support the startup and completion of clinical research studies and may supervise other clinical operations personnel.
Essential Functions:
- Achieves study objectives by working with CROs to set project priorities and milestones and resolve project conflicts from concept through final CSR
- Co-monitors with CROs CRAs as needed
- In conjunction with CRO, develops and tracks study timelines and quality metrics
- Ensures GCP and regulatory compliance is maintained through creation and management of CQP with Altimmune Quality group
- Assists in the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Assists in the logistics of IP, clinical lab samples and ancillary supply shipments
- Maintains professional expertise through familiarity with vaccine therapeutic area
- Manages, mentors, and develops direct reports
- Attends regularly scheduled cross-functional study team meetings with internal and external resources, CROs and site staff
- Participates in CRO and other vendor selection and management
- Participates in meetings with investigative sites, key opinion leaders and consultants as needed
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
- Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
Job Requirements (Essential knowledge, skills and attributes):
- 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
- Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
- Conscientious, influential person with an outstanding work ethic and strong personal discipline
- CRA certification (ACRP or equivalent) is strongly preferred
- Excellent organizational, leadership and problem-solving skills
- Excellent written and verbal communication skills
- Experience in leading cross-functional teams to meet goals and metrics
- Know-how in managing Phase I, II, & III clinical studies
- Experience in writing clinical study protocols, informed consent forms, and other clinical documents
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
- Working knowledge of MS Project for development and update of clinical study timelines
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