Why Syneos Health? Join a game-changing 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 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
1. 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 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. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Ensures customers are invoiced in a timely manner and follows up on receipt of payment. Reviews protocol, Case Report Forms, and edit specifications for consistency within each document, and cross-checks these documents against each other. 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).
2. Reporting - Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports as well as functional area plan to appropriate team members and senior management.
3. Communication - Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication. Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Reviews and approves information from PMs for internal 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 - Develops strong relationships with all of the current and prospective clients to generate new and/or add-on business for the future. Assists in the creation, development, and nurturing of key strategic client relationships. Collaborates with New Business Development efforts for Project Management input to generate sales. Networks to acquire new and/or repeat business. Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. Presents Company capabilities as well as develops operational strategy for Customer proposal defense meetings. Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.
5. Knowledge/Training - Demonstrates mastery of current therapeutic environment and drug development trends and facilitates the development of knowledge for more junior staff. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training. May review protocol to ensure Sponsor’s objectives are met and are in line with their Drug Development Program.
6. Project Leadership - Serves as the team leader by overseeing the project team, including the clinical team. Facilitates team building and communication. Works with management of other departments within the Company to ensure project related tasks and/or issues are resolved. Plans and projects resources required across all areas for studies. Serves as a project advisor to project teams regarding the operational and project management aspects of projects.
7. Management - Actively line manages and mentors other project management staff (which may include senior project management staff) and clinical monitoring staff in team leadership and project management skills, internal processes, and for project specific tasks. Provides guidance to the PMs to operationalize therapeutic expertise at the project level.
BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience. Extensive clinical research experience in a contract research organization (CRO), pharmaceutical, or biotechnology company. Extensive amount of active management of clinical research projects across functional areas, including full project life cycle management. Previous line management experience. 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, MS Project, email, and Internet. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Ability to act independently and proactively.
Job Project Management
Travel Yes, 50 % of the Time
Employee Status Regular