Project Manager

Summary The Project Manager is responsible for the management of, as well as the delegation of responsibility for ongoing management and oversight of clinical trial study projects as assigned. The Project Manager will direct activities to meet our client’s specifications, ensuring quality deliverables are 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.
Independently leads medium to high complexity, multi-regional (>2) global projects which may include oversight and leadership of supporting co-PMs and regional LabConnect PMs.
Participates in the handover process between Business Development (BD) and the Project Set-Up Team and in the training process of internal staff and handover from Set-Up 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.
Maintenance of project Dashboard including risk register (portions may be delegated)
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.
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.
Interfaces with Laboratory Services, Site Support Services, Project Coordinators, Digital Tracking, Business Development, Finance, Project Management, external Project Management, Specimen Management, Information Technology and Data Management personnel to ensure support and deliverables are met as outlined in specification documents and contracts.
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 Qualifications
Bachelor's degree (B.A./B.S.) from four-year college or university; and two years central laboratory project management experience.

Associates degree (A.A/A.S) will be considered if combined with 3+ years of central laboratory project management experience.

Must be experienced in customer service and possess excellent organization and interpersonal, communication and critical thinking skills. Must be adept at stress management.

Language Ability
Ability 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 Ability
Ability to perform calculations and manage budgets. Ability 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 exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills
To perform this job successfully, the individual must be proficient in Microsoft Office applications including Outlook, Word processing, Excel, and PowerPoint. SharePoint, SalesForce, and Microsoft Visio experience a plus.

Certificates and Licenses
Certification as an ASCP Medical Technologist and/or Registered Nurse is beneficial, but not required.

Supervisory Responsibilities
This position has no supervisory responsibilities.

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 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.

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.