Project Manager II -Clinical

Project Manager II - Clinical

Schedule : Monday - Friday (40 hrs / wk) 8 : 00 AM - 5 : 00 PM

Department : PharmaDx Group - 511

The PharmaDx department at ARUP Laboratories provides highly specialized diagnostic testing services to pharmaceutical partners in support of therapeutic programs for rare disease. The PharmaDx group specializes in developing companion diagnostic tests for approval by the US (FDA) and global regulatory agencies. The group has commercialized the only two companion diagnostic tests to be approved under FDA's HDE program for rare diseases. The group ensures all companion diagnostic and clinical trials projects are compliant with 21 CFR part 820, GCP, GMP, CLIA / CAP, ISO 13485, and / or other regulations as appropriate.

The PharmaDx group is looking for a Project Manager II - Clinical to manage clinical trial projects for therapeutic drug and CDx programs.

Primary Purpose : The Project Manager II-Clinical is responsible for the coordination and completion of all administrative functions associated with conduct of clinical trials supporting therapeutic drug programs and the PharmaDx group's companion diagnostic projects.

Their team might include associate project managers and quality control specialists. The Project Manager II will report to the PharmaDx Group Manager for the PharmaDx Clinical Investigations team. The Project Manager II has a working knowledge of drug development, clinical trial execution, validations and applicable regulatory requirements. The Project Manager II will independently manage projects small to large in scope and complexity. The Project Manager II will create and manage original study documentation including validation plans, validation data summaries, sample analysis plans, IRB regulatory binders, data transfers, study reports, quality metric reports and invoice requests, as applicable. The Project Manager II may also participate in Sponsor and / or regulatory body audits and inspections and assist in the response to audit reports and implementation of corrective and preventive actions, as applicable.

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 :

• Fields inquiries to ARUP by external companies regarding laboratory testing services.
• Creates and maintains a log of all Sponsor requests.
• Solicits input from ARUP medical directors or clinical lab supervisors as appropriate.
• Makes arrangements for Sponsor site visits / assessments / audits, including setting up appointments and obtaining necessary agreements such as Nondisclosure Agreements (confidentiality) and Business Associate Agreements (privacy).
• Leads visitors on facility tours, together with ARUP Marketing / Sales Support staff.
• Manages visitor review of important documents, procedures and reports via MasterControl, together with Technical Supervisors and Compliance / Quality Systems staff.
• Plans and hosts onsite visits, including quality assessments, audits and inspections.
• Coordinates ARUP's response to quality audit reports resulting from site visits.
• Together with the project leader, drafts test-specific compliance documents according to plans developed by the team, which could include those required to meet FDA, GCLP or CLIA regulations.
• Manages test Design History Files.
• Project Management : Provides project leadership, management, and oversight throughout the project, including the planning for ongoing support post-deployment. Project Manager II independently manages projects small to large in scope and complexity, and manages projects at any level of the organization. In relation to the responsibilities, the Project Manager II serves as a resource assigned to manage the project and its assigned resources in order to meet the project requirements and produce the project deliverables. Ensures that PharmaDx projects are completed on schedule and within budget. Responsible for organizing, communicating and evaluating team objectives for PharmaDx clinical programs. Draft and manage invoices, clinical study agreements and monitoring reports. PharmaDx clinical project managers additionally analyze, summarize and report clinical data. Ensures appropriate resources are available for a project and resolves project conflicts.
• Maintains a comprehensive understanding of project management and must possess strong problem-solving and leadership skills. Works closely with each project team to implement Design Control or GCLP principles, as applicable, and will manage associated processes and documents. Ensures appropriate resources are available for a project and resolves project conflicts.
• Provides leadership in developing study-related documents, which might include protocols, investigator files and informed consent documents, according to established ARUP protocol.
• Documentation Related Duties : Documents important milestones during test development / validation. Prepares meeting minutes / reports / summaries on behalf of Sponsors at specified intervals. Collects and organizes all documents generated during test planning, development and validation; documents important milestones.
• Manages time / effort reporting to Sponsors; drafts and tracks invoices; records payments. Works with internal and external contractors to submit tests to regulatory authorities, as needed. Collects documents for annual reporting following regulatory approval. Collects appropriate submission forms. Organizes test submission documents into master file, including Design Control documents. Collects documents pertaining to test re-validation or test changes. During the life of each collaboration, the Project Manager II will work to develop, organize and manage important internal documents, such as meeting minutes, SOPs, org charts, time accounting logs and invoices. Assists in the creation of new processes and procedures, as applicable.
• Maintains external professional relationships with investigators and sponsors, which may include physicians, medical research staff and outside consultants.
• Serves as a liaison between study sponsors, investigational sites and the clinical research organization.
• Maintains professional internal relationships with ARUP medical directors, R&D, technical operations, purchasing and other departments and individuals.
• Maintains a strong scientific knowledge and research skills.
• 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.

Qualifications

Education

Required

Associates Degree or better in Business or related field.

Preferred

Bachelor's Degree or better in Business or related field.

Master's Degree or better in Business.

Experience

Required

Two years of managing complex project(s)

Two years of experience in research or clinical laboratory setting

Bachelor's degree in Business Management, Project Management, Medical Laboratory Science, Biology, Chemistry or equivalent degree OR Associate's degree and PMP Certification

Preferred

Excellent written communication skills, as exemplified by a writing example taken during the interview process

Excellent oral communication skills

Advanced experience with Microsoft Word, Excel and PowerPoint

Experience in pharmaceutical development

Management experience of laboratory projects

Experience in Good Laboratory Practices environment

Experience drafting and editing SOPs

Experience drafting responses to quality audit reports

Experience with MasterControl document control software

Experience in quality control and quality assurance

PMP Certification

Licenses & Certifications

Preferred

Project Management Prof