SEEKING LOCAL CANDIDATE TO FILL OPENING FOR PROJECT MANAGER The Project Manager is responsible for the overall project management from project kick-off through clinical study report completion and FDA submission, ensuring that the project objectives have been met. The Project Manager is also responsible for review and comment on company-wide and department-specific SOP, resource monitoring, and promotion of SOP compliance.
- Participate in the periodic review and revision of departmental policies and SOPs
- Collaborate interdepartmentally on the proposal development process.
- Participate in bid defense presentations and meetings.
- Direct the conduct of assigned projects and activities associated with the project.
- Ensure compliance with FDA regulations, ICH/GCP, and SOPs for projects filed under a U.S. IND, IDE or other FDA requirements.
- Manage resource and financial aspects of the clinical study.
- Communicate effectively with internal and external members of senior management, the project team, investigators and site personnel, and expert physicians.
- Manage problem identification and resolution in order to adhere to the project time lines and budget.
- Assume certain duties of CRA or other team members in order to meet project goals.
- Lead the development, implementation and review of the Project Plan.
- Assist with IND and NDA coordination and preparation.
- Develop a working knowledge of assigned protocols.
- Design, write, and review draft protocols, draft CRF, informed consent, operations manual and other documentation required for conduct of a project.
- Resolve issues regarding grant negotiations, budgets and contracts with investigational sites.
- Review Clinical Research Associate visit reports to assure report adequacy and adherence to project-specific monitoring plans, applicable SOPs and FDA regulations and guidelines.
- Supervise the planning and facilitation of investigator meetings.
- Review recruitment strategy for meeting target enrollment of clinical protocols against target project goals.
- Review and comment on draft analysis outputs (tables, listings, and graphs) to be incorporated into Final Study Reports (FSR), integrated summaries and NDAs.
- Write drafts and/or review appropriate sections of the FSR.
- Participate in interactions/meetings with regulatory authorities, as needed.
- Work with Data Management staff to review case report data in-house, and interface with study personnel to resolve data queries
- Recommend outsourcing when appropriate and interact with appropriate project team members to ensure that outsourcing to CROs/vendors will meet expected performance standards for quality, timeliness and budget.
- Co-monitoring and auditing, as needed.
- BA/BS in nursing, biological sciences or related field.
- Five years of clinical research experience with a CRO, pharmaceutical or biotech firm.
- Progressively increasing clinical research experience which includes project management, staff supervision and/or monitoring experience.
- Extensive knowledge of clinical trial management and FDA regulatory requirements.
- Working knowledge of Good Clinical Practices (GCPs).
- Strong oral /written communication and negotiation skills.
- Strong interpersonal and leadership skills and abilities.
- Detail-oriented with strong planning, organizing and follow-through skills.
- Proficient in Microsoft Office software.
- Ability to work effectively both independently and in a team environment.