1001 Main Street, Suite 600
Job Category: Clinical: Clinical Operations and Development
Job Number: 2083
As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee CRO conduct and progress when outsourcing is required. The CPM understands all aspects of project management and ensures that the study meets projected milestones within budget. The CPM may assist the director in managing and implementing project management team meetings.
- Coordinate the standardization and maintenance of status reports and other information sources.
- Facilitate communication with external partners and key therapeutic area investigators when issues arise that affect multiple projects and/or TA(s).
- Work with project leadership to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues.
- Participates in the development of risk mitigation strategies.
- Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities.
- Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes.
- Provide input into the development of the CRF (data capture forms) design and completion instructions.
- Collaborate with the TA(s) management staff & cross-functional management teams, in development of budgets and timelines for new studies.
- Performs ongoing vendor management (e.g. CROs, IVRS) including independent negotiation of vendors scope of work and budgets, performance management and issue resolution.
- Ensures accuracy and timeliness of vendor and site payments.
- Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward.
- Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
- Review visit reports and escalate issues to medical and operational leaders.
- Ensures trial adherence to ICH/GCP/local regulations.
- Calculate clinical and non-clinical IMP requirements.
- With cross-function departments to ensure timely manufacture, packaging and IMP shipment to sites.
- Facilitate SAE medical review process.
- Assist medical and project leaders with safety reporting compliance.
- Coordinates data cleaning activities.
- Reviews query aging reports against timeline and works with functional team members or CRO to resolve queries according to plan.
- May review clinical data (listings and tables)
- Have an understanding of IND/NDA submission requirements.
- Assist with the review and revision of new and revised IND documents.
- Conduct quality control (QC) audits on annual and ad hoc IND updates.
- Serves as functional manager for contract study monitors
Required Education & Qualifications:
- Bachelor of Science (applied science) or registered nursing degree (Masters preferred).
- At least three years of experience in clinical trial project management.
- Excellent project management skills.
- Direct and positive experience communicating with Clinical Operations teams and study sites.
- Must have excellent organizational skills and work effectively in a fast paced environment.
- Must possess good analytical and researching skills.
- Must be proficient in Microsoft Word, Excel, Office and MS Project.
- Ability to education and train junior staff.