Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.
Provides customer-focused leadership in managing clinical trials across various phases and functional areas and assigned clinical staff. Accountable for the successful execution of all assigned projects, where success includes on-time, on-budget, high quality/compliant project results that lead to satisfied customers. Acts as an integral part of the selling team through involvement in proposal development and bid defense. Serves as the primary liaison with Customers, vendors, and Investigator Sites. May have line management responsibility for assigned clinical staff. 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, which may be global, with limited interaction from supervisor.
Project Administration - Acts 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. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Serves as the team leader by overseeing the project team, including the clinical team. Acts as a liaison and facilitator between other operation departments within the Company for project related tasks and/or issues. Plans and projects resources required across all areas of the study. 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. Develops and maintains project plans for the study in accordance with SOPs and Work Instructions (WI). Performs ongoing review of project financial status of studies within his/her responsibility. Alerts senior management to potential issues and ensures necessary corrective action is taken. Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files (TMFs), are complete and audit ready. Assists in the negotiation and contracting process with outside vendors (labs, printers, etc).
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.
Communication - Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and Customer presentations. Ensures adequate documentation of each communication. Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.
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.
Knowledge/Training - Demonstrates working knowledge of current therapeutic environment and develops knowledge of drug development trends. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. Project Leadership - Manages a project as project manager. Acts as a liaison and facilitator between other departments within the Company to ensure project related tasks and/or issues are addressed. Management - May be required to actively line manage other project management team members and may manage clinical monitoring staff.
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, pharmaceutical, or biotechnology company. Clinical research organization (CRO) and relevant therapeutic experience preferred. Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a hospital setting, pharmaceutical company, or CRO preferred. Thorough knowledge of regulatory requirements, drug development, and clinical monitoring procedures. Demonstrated proficiency with ICH/GCP guidelines. Keen insight, independent judgment, and tactful discretion. 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 handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of th...e most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.