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Senior Project Manager - Early Development Services - Johnson City

Company: LabConnect INC
Location: Johnson City
Posted on: November 29, 2019

Job Description:

Founded in 2002,--LabConnect--provides global central laboratory services including routine and esoteric laboratory testing, kit building, sample management, biorepository and scientific support services for biopharmaceutical and CRO clients in support of their clinical trials. LabConnect is a central lab headquartered in Seattle with a primary operating facility in Johnson City, TN. We're looking for professionals that share our core values of building long-term successful relationships, self-awareness, passion to excel, creativity and interconnectedness.SummaryResponsible for the provision of project management services for the company's Early Development Services projects. The Senior Project Manager will work closely with the Director, Associate Project Managers and other Project Management Staff within Early Development Services to provide operational support for research protocols, phase 0/phase I protocols and SampleGISTICSTM projects. The Senior Project Manager will manage project activities to our client's specification, ensuring quality deliverables on time and within budget by performing the following duties.ResponsibilitiesDirect supervision of Project Managers, Associate Project Managers, and Project Coordinators and their respective clinical trial projects.Assist with hiring and assignment of project managers to include recruitment, selection, coaching and development as well as retention.Management of Digital form Creation/Mapping/Coding/validation of forms for digital pen study set ups.Manages QC of digital forms and supply kits containing digital forms.Meet with directors and other manager/supervisors to stay informed of changes affecting operations.Manages troubleshooting unsuccessful digital pen installations as needed; notifies sites when a successful site set up form has been received.Create training material for investigators and internal staff.Oversees the management of digital pen training sessions for study sites.Coordinate with Director and other Project Management Staff to develop study set up activities, SOP's, SOW's, lab manuals, requisitions, digital pen set up and training, and provide technical support to the clinical sites as needed.Set up tracking or specialty services from collection to analysis, and assist with the relevant data management components.Reviews project design and development with supervisor.Works with the client's clinical study managers to define early development and/or sample tracking needs and to develop appropriate training materials for investigator's sites and internal staff.Ensure that the samples are being collected as per the visit schedule and agreement, using the appropriate kits, documented accurately, and tracked for appropriate testing and data analysisDetermines supplies required for investigator kits.--Provide quality assurance assistance and/or oversight to the assembly process.Develops protocol and visit-specific requisitions as needed.Performs QC of all protocol related documents before they are released to the client.Ensure smooth operations of multiple projects simultaneously on a global basisAct as primary project contact for external stakeholders including client (Biopharmaceutical Company or CRO), partner labs, data management companies and other vendors.Coordinate and communicate project status and deliverables amongst multiple internal departmentsOversee development and maintenance of all project-related documentation (includes proprietary software, SharePoint and other tools)Develop and conduct training for internal and external stakeholdersMonitor clinical trial progress and proactively anticipates issuesCoordinate specimen testing, transfer and reporting with external laboratoriesTrack investigator site and study participant activity and identify potential issuesInterfaces with laboratory, customer service, business development, external project management, information technology, and data management personnel.Represents LabConnect at investigator meetings.Works with client clinical operational team members to ensure appropriate communication channels are maintained and reporting schedules are followed.Coordinates specimen transfer and reporting with external referral laboratories.Assures new clinical test procedures and new IT database validations are completed and acceptable prior to specimen receipt and reporting for specific project.Assures all investigators site information is validated in applicable databases.Participates in internal quality assurance unit.Education/ExperienceBachelor's degree from a four-year college or university (Bachelors in the natural sciences preferred). Two years related clinical and/or laboratory or related experience required. Must be experienced in customer service and possess excellent organization and interpersonal skills. Ability to navigate software and databases is a must. Very high attention to detail and excellent multi-tasking skills is required for success in this position.Language AbilityAbility to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.--Ability to write reports, business correspondence, and procedure manuals.--Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.Reasoning AbilityAbility to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Computer SkillsTo perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications including Word, Excel, and Power Point.Supervisory ResponsibilitiesThis job has supervisory responsibilities.Work EnvironmentThe noise level in the work environment is usually moderate.Physical DemandsWhile performing the duties of this job, the employee is frequently required to sit and talk or hear.--The employee is occasionally required to stand; walk and reach with hands and arms.--The employee must occasionally lift and/or move up to 50 pounds.--Specific vision abilities required by this job include close vision and ability to adjust focus.This job description should not be construed to imply that these requirements are the exclusive standards of the position.--Incumbents will follow any other instructions and perform other related duties as may be required by their supervisor.--Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.We value our employees' time and efforts. Our commitment to your success is enhanced by our competitive compensation and extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.EOE

Keywords: LabConnect INC, Johnson City , Senior Project Manager - Early Development Services - Johnson City, Executive , Johnson City, Tennessee

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