Clinical Science Project Manager
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POST DATE 9/14/2016
END DATE 11/11/2016
JOB DESCRIPTIONMore information about this job:
ERT is the leading cloud platform solutions provider that captures quality efficacy and safety endpoints, harmonizes data from any clinical source system, and delivers real-time insights for optimum trial performance innovating better health for over 40 years and tomorrow. ERT s combination of technology, services, and consulting increases the accuracy and reliability of patient data and improves the efficiency of the clinical development process throughout the product lifecycle. ERT provides sponsors and CROs with the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments (COAs including patient, clinician, and observer reported outcomes). ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
ERT is looking for a Clinical Science Project Manager to be responsible for delivering the highest quality consulting and rater training services with on time delivery.
The Clinical Science Project Manager will interface with the clients as well as the project team. As a member of a team of accomplished scientists, clinicians, and data analysts, the Clinical Science Project Manager manages logistics for the clinical science team projects interfacing with Sales, Marketing and Client Services functions in a software company that creates electronic data collection systems for clinical trials.
* Facilitate gathering requirements for studies
* Manage project timelines and keep clients and internal teams informed
* Manage the cross functional team assigned to the trial to ensure product quality and timely delivery
* Manage contract obligations and compile out-of-scope documentation
* Attend Investigator Meetings as necessary
* Attend post deployment debrief meetings
* Manage resolution of client issues and problems
* Monitor trial hours/cost against project budget
* Ensure Project staff is updating their timesheets for Projects assigned
* Together with Account Executives, be responsible for ensuring client satisfaction and establishing client references
* Interact with clients at high level to deal with all issues of escalation from the operational team
* Make regular account management calls with client to ensure all needs are being met
* Attend client meetings with Science/Sales to represent the Client Service function and describe implementation and training methodologies
* Prepare and deliver presentations to highlight how the project should be rolled out
* Contribute to product development decisions for eCOA and science services
* Participate in presentations at professional forums, conferences & meetings
* Participate in the preparation and review of publications, abstracts & white papers
* Support projects which are designed to obtain marketing information
Acquire and maintain critical knowledge to support sales and ERT project teams
* Maintain knowledge base regarding regulations or scientific advances that influence ERT s eCOA services to customers, such as the 2009 PRO Guidance from the FDA, all new guidances (EMA/FDA), current literature and best practices based on data analysis and/or internal research efforts
* Participate in discussions on behalf of the client with scientists such as questionnaire copyright holders, to facilitate ERT s deliverables to clients.
Support and drive science sales and deliverables including rater training, clinical data surveillance and consulting services
* Rater training will include such services as training of clinical site staff raters and training for subjects and caregivers.
* Consulting services will include such items as literature reviews, migration studies and instrument development & validation.
* Clinical data surveillance will include using algorithms and/or audio or video surveillance review & remediation to identity data that is discordant or illogical.
Support and drive internal research pipeline and external outreach including webinars, abstracts, papers, white papers and related content
Product and Process Development
* Gather client feedback and share with Clinical Science/Sales teams
* Assist in the evaluation of new product features
* Develop project management procedures and communicate project status and issue
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
* MBA, BS, BA or equivalent
* Minimum of three years of experience in the execution of clinical trials and/or health care software implementation or equivalent
* Proven experience in client relations and/or account management
* Demonstrated ability in project management
* Demonstrated ability in managing contracts and scope
* Comfortable interacting with clients at all levels
* Familiarity with FDA regulatory processes and clinical research processes
* Self directed - comfortable working in a fast paced environment with little direction
* Experienced and comfortable with project management software, developing presentations, and delivering presentations
* Business driven and business growth savvy.
* Polished presenter with considerable experience in pre and post-sales environments for eCOA/related industries
* Comfortable and fearless learning new roles, versatile, fast learner
* Team leader & team player
* Highly interactive across the enterprise, comfortable with technology platform and science bridging ERT technology and services to the clinical trial needs of our clients
* Highly skilled in the sales and delivery of science services including rater training, clinical data surveillance and/or consulting services.
* Excellent interpersonal and communication skills; Ability to understand and communicate with representatives from the range of disciplines within biopharmaceutical development
* Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.