Clinical Support Specialist
Immediate need for a talented Clinical Support Specialist that brings experience to the Pharmaceutical Industry. This is a 6 month contract opportunity with long-term potential and is located in RTP, NC. Please review the below job description and contact me ASAP. Basic qualifications: Associate Degree; HND/HNC Degree or Bachelors Degree with proven applicable experience Experience in pharmaceutical industry or health-related field Proven experience of applying customer service and technical skills Proven ability to work effectively within interdisciplinary teams Solid technical background and computer proficiency in a variety of databases and software applications; technical aptitude Solid knowledge of clinical development processes and procedures, including related functional areas and regulations as required Ability to work on complex or multiple project assignments Demonstrated ability to manage tasks with limited supervision Exhibits enhanced customer service orientation and excellent interpersonal skills with ability to communicate professionally Preferred qualifications: Experience in one or more of the following technologies is preferable: Microsoft Project or similar planning software IntraLinks Cognos Reporting tools Microsoft SharePoint SQL Oracle (database programming / query skills) Software development experience in a regulated pharmaceutical environment 1st and/or 2nd level system support experience Track record of providing high quality customer support Details: The purpose of the Business Systems Support Analyst role is to provide high quality support for our end-to-end clinical trial systems. This position is situated in a business facing department. Many of our systems are used by a global community spanning thousands of users. We’re at an exciting point in our evolution as we continue to push the boundaries of our clinical trial technical landscape. Our remit is to support users of our clinical systems by: Facilitating the resolution of technical problems relating to our clinical trial systems either directly or indirectly via internal or external IT partners Continuously improving our systems and workflows to deliver clinical trial improvements - time/cost/quality Ensuring that our clinical trial systems conform and remain compliant with regulatory validation requirements i.e. ICH GCP, FDA CFR Part 11 etc Ideal applicants will have: Experience in the application and support of clinical trial processes and technologies Several years experience actively supporting clinical trial study teams Thorough understanding and experience of validating systems according to ICH GCP / FDA CFR Part 11 guidelines Proven track record of effectively communicating and influencing across business and IT boundaries Experience in Microsoft Project or similar planning software, IntraLinks, Cognos Reporting tools and Microsoft SharePoint Good communication skills Day-to-day tasks may include: Liaising with clinical project teams and support organizations to ensure tasks are completed to schedule Coordinating business testing and tracking testing documentation Planning, tracking and executing decommissioning tasks Report creation and generation Conducting interviews with users to ascertain effectiveness of applications Conducting remedy ticket reviews; troubleshooting access issues and removing access Providing primary internal support for IntraLinks application, including providing contact for transition from IntraLinks to eDX (electronic document exchange); troubleshooting any transition issues, etc. This position is an opportunity to join an experienced clinical trial support organisation that values the contribution of its people and empowers them to make an impact in our pursuit of delivering high quality clinical studies. Key Purpose of role: Serve as a clinical execution functional area support expert, working in a matrix environment partnership with one or more cross-functional business groups to develop, standardize, improve and maintain business, technical, and system functionality and processes to achieve the expected business benefits. Serves as point of contact for questions related to assigned functional areas and areas of expertise for internal and external customers, as appropriate. Serves as an internal expert in an assigned area or areas. Responsible for evaluating the business requirements for the assigned user group(s) to ensure that needed functionality and performance is provided by the applicable performance-related systems. Key Responsibilities: Ability to understand the impact of process and technology and their changes on the business. Lead interfaces with other departments, team members or groups to clarify and resolve issues and better define user requirements. Lead the implementation of resolutions derived from customer feedback. Develop strategies for improving relationships where necessary. Contribute to the standardization and dissemination of best practices across assigned business area. Prepare communications and relevant materials in support of Local Experts. Design, develops and issues newsletters, as needed With limited direction, provide on-going guidance to assigned groups for the effective use of the systems. Propose specific training as needed. With limited supervision provide support to one or more business groups as directed, ensuring their satisfaction with the systems. Review data and identify concerns, causes and provide solutions. Manages own workload and priorities within overall guidelines set by others. Expert knowledge of technical components and ability to innovatively apply that knowledge to the business. Organize work to meet priorities and customer expectations. With limited direction develop process documents with input from relevant stakeholders Participate and contribute in cross functional expert user groups Participate in the implementation of key organizational process improvement initiatives. Provide Help Desk Support for queries initiated by users in the group, and ensures timely and acceptable resolution. Support training efforts related to clinical planning and management systems and processes Support creation and maintenance of web-enabled documentation. Support Local Experts by conducting training, 1:1s and hands-on training, as appropriate. Develop service metrics to quantitatively characterize current services to agreed service levels Analyze trends to identify process weaknesses and service needs With limited supervision, provide business input to the testing and validation of relevant aspects of the system(s) software and architecture as modifications and upgrades become available to ensure acceptability by the assigned business user group(s). Our client is a leading pharmaceutical institution and we are currently interviewing to fill this and other similar contract positions. Qualified candidates should apply NOW for immediate consideration. Please email me the most current version of your resume and refer to 12-04023 in the subject line. Regards, Glenn Fitzgerald Technical Recruiter 331 Newman Springs Road Building 3, 2nd Floor, Suite #350 Red Bank, NJ 07701 firstname.lastname@example.org www.diversant.com Due to the nature of the position, Diversant can only consider direct applicants. Third party resumes will not be considered. Diversant is one of the largest African-American owned IT staffing and solutions firms in the U.S. We are a fully-certified Minority Business Enterprise (MBE) provider, dedicated to the promotion of diversity in the supply chain and throughout the workplace. Equally important to us is our commitment to providing the highest level of service to all our clients, consultants, and partners. We believe that diversity in all its forms leads to greater opportunities for consultants and partners, and to more innovative solutions for clients.
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