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 trialsLabconnect is a central lab headquartered in seattle with a primary operating facility in johnson city, tnWe’re looking for professionals that share our core values of building long-term successful relationships, self-awareness, passion to excel, creativity, and interconnectedness.
Summary
The project manager, project management, is responsible for oversight of assigned clinical studiesS/he will participate in the development of statements of work (sow) to define client expectations and will perform duties associated with day-to-day oversight of ongoing clinical trial study projects, throughout the life of the trial to ensure quality deliverables on time and within budget.
Responsibilities
Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.
Participates in the handover process between business development (bd) and the project initiation services team (pis), and in the training process of internal staff and handover from pis to the pm.
Primary project contact with sponsors and contract research organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to.
Serves as the first point of contact for management issues related to clinical trials.
Works closely and in coordination with clinical laboratory management and directors in support of clinical trials.
Review of reports and documents, including enrollment logs, pending test reports, reporting from other laboratories, issue logs, shipping manifests, and other documents that assist with study oversight.
As needed, interfaces with laboratory(ies), bd, operations, and data management.
Liaise with project coordinators to ensure study-related tasks have been performed, and with the assigned data manager to ensure data is delivered on time per the sow.
Review and analyze operational, quality, and performance-related metrics to assess the success of study oversight activities.
Liaise with managers/supervisors in other departments to stay informed of operational changes.
Collaborate with project managers in partner laboratories to provide a global overview of study management.
Coordinate requests for shipment of stored samples as directed in the sow.
Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices.
Creates training materials for investigator meetings as applicable.
Represents labconnect at the client and/or investigator meetings.
Performs other related duties and tasks as necessary or as assigned.
Education and qualifications
Associate’s degree, preferably in laboratory science, or equivalent combination of education and experienceStrongly preferred: medical technology or mlt degree with 3+ years related laboratory experience, or experience in the clinical trial industry in a project oversight roleExcellent organization, communication, multitasking, and interpersonal skillsCustomer service/client relationship management skills
Language ability
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulationsAbility to write reports, business correspondence, and procedure manualsAbility to effectively present information and respond to questions from managers and clients.
Math ability
Ability to perform calculations and manage budgetsAbility to apply mathematical concepts to budget management for clinical trials and metrics analysis.
Reasoning ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization existsAbility to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer skills
To perform this job successfully, the individual must have a working knowledge of microsoft office applications including word processing, spreadsheets, and powerpointSharepoint and microsoft visio experience a plus.
Certificates and licenses
Certification as an ascp medical technologist and/or registered nurse is preferred.
Supervisory responsibilities
Some supervision of employees in the early development/scientific operations department may be requiredCarries out supervisory responsibilities in accordance with the organization's policies and applicable lawsResponsibilities may include interviewing, hiring, training, and mentoring employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Work environment
The noise level in the work environment is usually moderate.
Physical demands
While performing the duties of this job, the employee is frequently required to sit, talk, and hearThe employee is occasionally required to stand; walk and reach with hands and armsThe employee must occasionally lift and/or move up to 30 poundsSpecific vision abilities required by this job include close vision and the ability to adjust focus.
This job description should not be construed to imply that these requirements are the exclusive standards of the positionIncumbents will follow any other instructions and perform other related duties as may be required by their supervisorReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
We value our employees’ time and effortsOur 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 companyPlus, we work to maintain the best possible environment for our employees, where people can learn and grow with the companyWe strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
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