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Manages 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/or global projects, across various phases and functional areas, with limited interaction from supervisor.
1.Project Administration - Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customers and the Company's contractual agreement.Coordinates project organization, implementation, and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files are complete and audit ready.Assists in the negotiation and contracting process with outside vendors (labs, printers, etc).May perform or oversee site feasibility assessments. Reviews protocol, Case Report Forms and edits specifications for consistency within each document, cross-checking these documents against each other. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.
2.Communication - Independently prepares and presents study material at client meetings and communicates outcomes to project team at 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.
3.Business Development - Develops strong relationships with current clients to generate new and/or add-on business for the future.Supports the Business Development department by participating in Customer proposal development as well as providing information on the Company's capabilities, patient populations, etc.May present Company capabilities as well as project management specific responsibilities at Customer proposal defense meetings.
4.Knowledge/Training Demonstrates mastery of current therapeutic environment and drug development trends.Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.
5.Project Leadership - Manages a project as project manager. May manage more complex/larger global projects and/or programs.Acts as a liaison and facilitator between other departments within the Company to ensure project related tasks and/or issues are addressed.
6.Management - Actively line manages and mentors other project management team members and clinical staff. Facilitates team building and communication.
May represent company at professional meetings or seminars. 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.Moderate clinical research experience in a contract research organization (CRO), pharmaceutical, or biotechnology company. Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, pharmaceutical company, or CRO. Some time must have been spent actively managing clinical research projects across functional areas.Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures.Demonstrated proficiency with ICH/GCP guidelines.Keen insight, independent judgment, and tactful discretion.Strong 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. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
Disclaimer:Tasks, duties, and responsibilities as listed in this job description are not exhaustive.The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees
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