This job was found on ExpatJob.com
Job URL: https://www.expatjob.comPrint Job
$ 6500 to $ 7200 per month
United States, UNITED STATES
October 7 2021
We seek a Senior Project Manager-Oncology to manage projects from proposal development to final deliverables to the Customer ranging in size and complexity from single service studies to full scope, multiple protocol projects, and global projects, across various phases and functional areas, with limited interaction from a supervisor.
- Project Administration:
• Acting as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Coordinating project organisation, implementation, and management activities between all Company operations and the client.
• Managing the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
• Overseeing and tracking site payment issues as required. Alerts Finance on the need for Customer invoicing.
• Overseeing the regulatory document collection and submission process as well as ensuring project documentation, including Trial Master Files, are complete and audit ready.
• Assisting in the negotiation and contracting process with outside vendors (labs, printers, etc.).
• Performing or overseeing site feasibility assessment as required as well as reviewing protocol, Case Report Forms and edits specifications for consistency within each document, cross-checking these documents against each other.
• Developing and maintaining project plans for the study by Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Maintaining and evaluating project progress by maintaining timelines and other tracking/analysis tools as well as producing and distributing status, resourcing, tracking reports and functional area plan to appropriate team members, and ensuring senior management.
• Performing ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken
• Preparing and presenting study material at client meetings and communicating outcomes to project team at review meetings independently.
• Attending clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and training plans.
- Business Development
• Developing strong relationships with current clients to generate new and add-on business for the future.
• Supporting the Business Development department by participating in Customer proposal development as well as providing information on the Company's capabilities, patient populations, etc.
• Presenting Company capabilities as well as project management specific responsibilities at Customer proposal defence meetings.
• Demonstrating mastery of current therapeutic environment and drug development trends.
• Facilitating team training in accordance with the protocol and project requirements, including therapeutic, protocol specific, and process training.
- Project Leadership:
• Managing a project as project manager as well as managing more complex/larger global projects and programs.
• Acting as a liaison and facilitator between other departments within the Company to ensure project related tasks and issues are addressed.
• Managing the active line as well as mentoring other project management team members and clinical staff.
• Facilitating team building and communication.
- Representing company at professional meetings or seminars as at when required.
- Performing 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.
- Moderate clinical research experience in a contract research organisation (CRO), pharmaceutical, or biotechnology company.
- A technical and managerial experience in conducting multi-national and local clinical trials in a hospital setting, pharmaceutical company, or CRO.
- Experience in managing clinical research projects across functional areas actively.
- Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures.
- Demonstrated proficiency with ICH/GCP guidelines coupled with keen insight, independent judgment, and tactful discretion.
- Strong presentation, documentation, and interpersonal skills as well as a team-oriented approach.
- Excellent computer skills in Word, Excel, PowerPoint, email, and Internet. Basic computer skills using MS Project.
- Ability to mentor and manage new staff and handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment as well as being flexible.