Summary The Project Manager, Project Management, is responsible for oversight of assigned clinical studies. S/he will participate in 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 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 client and/or investigator meetings.
Performs other related duties and tasks as necessary or as assigned.
Education and QualificationsAssociate’s degree, preferably in a laboratory science, or equivalent combination of education and experience. Strongly preferred: Medical Technology or MLT degree with 3+ years related laboratory experience, or experience in the clinical trial industry in a project oversight role. Excellent organization, communication, multitasking and interpersonal skills. Customer service/client relationship management skillsLanguage AbilityAbility to read, analyze, 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 managers and clients.Math AbilityAbility to perform calculations and manage budgets. Ability to apply mathematical concepts to budget management for clinical trials and metrics analysis.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, the individual must have a working knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint. SharePoint and Microsoft Visio experience a plus.Certificates and LicensesCertification as an ASCP Medical Technologist and/or Registered Nurse is preferred.Supervisory ResponsibilitiesSome supervision of employees in the Early Development/Scientific Operations department may be required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities 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 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, talk and 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 30 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
