1. Project Administration – Assists with managing the executed contract and financial aspects of assigned projects. Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed. May oversee and tracks site payment issues as required. Alerts Finance to the need for Customer invoicing. Reviews protocol and draft Case Report Forms for consistency within each document. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. Performs ongoing review of project financial status of studies within his/her responsibility; alerts senior management to potential issues and ensuring necessary corrective action is taken. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master File, are complete and audit ready. Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, drug packaging, labeling and storage, and Interactive Voice Response System companies.
2. Reporting – Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management.
3. Communication – Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication. Prepares information for internal review meetings. May present prepared information at project review meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.
4. Business Development – May participate in proposal and investigator grant determination. May participate in Customer proposal development.
5. Knowledge/Training – Develops knowledge of current therapeutic environment. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
6. Project Leadership – May manage a project under supervision. Acts as a liaison and facilitator between other departments within the company to ensure project related tasks and/or issues are addressed.
7. Management – May have limited line management responsibility.
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience. Minimal related experience. Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred. Basic understanding of clinical research fundamentals. Presentation, documentation, and interpersonal skills as well as a team-oriented approach. Proficient computer skills in Word, Excel, PowerPoint, email and Internet. Basic computer skills using MS Project preferred. Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
Tagged as: (CRM), Project Manager, South Korea
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