PharmaDx Senior Project Manager

Schedule:

Monday - Friday (40 hrs/wk)

8:00 AM - 5:00 PM

Department: PharmaDx - 511

Primary Purpose:

The PharmaDx Senior Project Manager works within the PharmaDx group to manage the activities of the group's pharmaceutical projects. A Senior Project Manager may be focused on the technical, logistical, and operational aspects of the projects or on the regulatory, quality and compliance aspects of the projects as noted below. This position works with limited supervision with wide latitude for independent judgment and decision making.

Technical, logistical, operational focus: Ensures projects are completed on schedule and within budget. Drafts, organizes and manages all relevant documentation throughout project life cycle. Analyzes and summarizes clinical study data and communicates this information to sponsors.

Regulatory, quality, compliance focus: Participates in development of regulatory strategy and manages regulatory processes and all relevant documentation and files throughout project life cycle. Manages quality and compliance of projects and liaises with corporate CQS representatives. Prepares for and hosts audits from both sponsors as well as regulatory authorities and prepares audit responses. Performs external supplier audits and manages compliance with regulatory requirements. Oversees change management for PharmaDx projects.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Provides project leadership, management, and oversight throughout projects, including the planning for ongoing support, compliance and quality post-deployment.

Manages projects and their assigned resources in order to meet requirements, timelines and deliverables and to maintain compliance with applicable standards, regulations and policies.

Works closely with each project team to implement Design Control or GCLP principles, as applicable, and manages associated processes and documents.

Manages FDA submission documents and correspondences, and oversees important post-market reporting and documentation processes.

Plans and manages clinical trials in order to achieve quality results, as well as compliance with applicable regulations and policies.

Serves as a liaison between applicable internal ARUP departments, in order to ensure that all targets and requirements are met.

May serve as the primary liaison with ARUP compliance and quality, as well as external regulatory authorities and institutions.

Creates new processes and procedures, as applicable. Prepares training modules for processes and procedures. Prepares and conducts training with project teams.

Maintains professional relationships with all relevant internal and external stakeholders.

Maintains a strong scientific knowledge and research skills, including a deep understanding of the methods and procedures utilized in PharmaDx programs.

Other duties as assigned.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)