Project Manager - Job Number 1730
Date posted: March 20, 2008
Location: Research Triangle Park, NC
Job type: Full-time
Industry: Biotechnology
Description:
We are currently seeking a Project Manager to join our Clients team. Our Client provides the technology to gather, analyze, and integrate data from clinical trials faster and more efficiently than ever before.
Responsibilities include:
Managing and co-ordinating all technical and service aspects of an Interactive Response Technology project used for randomization, supplies management, and forecasting for clinical trials. This will range from initial discussions with clients, development of the project specifications, documentation aspects of setting up the project and management of all project related activities through to study completion. The role will be responsible for ensuring all project work is completed to the sponsor’s satisfaction, enduring quality deliverables on time and within budget and in accordance with policies and procedures.
•Co-ordination and communication of all relevant activities, both internal and external, to design a clinical system to meet the need of the study.
•Author design specification and other project documentation to support the system development. Work with the project team to finalize the required documents.
•Overall responsibility for ensuring activities come together in a timely manner to meet the client and study requirements, including regular communication with team members across the globe to ensure project tasks are on target.
•Management of the system lifecycle (SLC), Project Validation Testing (PVT), user testing (UAT) and the ‘go live’ process.
•Travel to conduct training at investigator meetings as required by client.
•Collect information on team performance against contract, customer expectations and project baselines, set and monitor goals and objectives.
•Lead problem solving and resolution efforts.
•Act as primary contact with sponsor, including participation in client meetings, bid support meetings, teleconferences to ensure communication and maintain schedule.
•Provide input for the development of proposals for new work and manage project budgets.
•Provide input to line mangers on their project team members’ performance relative to project tasks.
•Partner with other project managers on a cross functional basis to develop and implement business process improvement activities.
•Ensure that work is conducted in accordance with standard processes, policies and procedures and meets quality and time line metrics.
•Assessment of clinical protocol and other client supplies study specifications to help design supply chain solutions to meet the needs of the trial.
•Forecasting and tracking of all clinical trial supplies to ensure that all investigator sites are provided with sufficient medication for all patient visits (where appropriate) throughout the course of the trial.
Requirements:
•Bachelor's degree in sciences, technology or related field and 3-5+ years clinical research or pharmaceutical experience including 0-2 years project management experience.
•Experience in a key CRO/Pharmaceutical operational function, e.g., data management, clinical operations, laboratory, pre-clinical; or equivalent combination of education, training and experience is desired.
•Experience with Interactive Voice Response or Electronic Data Capture is a plus
•Excellent communication skills, both written and verbal
•Strong customer service ethic with ability to establish and maintain effective working relationships with co-workers, managers and clients
•Good problem solving and organizational skills
•Accuracy, with an eye for detail and results focused
•Analytical decision making
•Team player & flexible
•Good computer skills, including knowledge of MS office applications
•Knowledge of the drug development process a
For confidential consideration please submit a resume and salary history to Claire@fullscalesolutions.com
Full Scale Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Category: Pharmaceutical/Biotech
Company: Full Scale Solutions
Full Scale Solutions, Inc. is a Human Capital management company that provides exceptional recruiting solutions to companies to help them grow.