Project Manager I/II -Clinical - ARUP Laboratories
Salt Lake City, UT
About the Job
Description
Schedule: Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM
Department: PharmaDx - 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 I -Clinical to manage clinical trial projects for therapeutic drug and CDx programs.
Primary Purpose :
The Project Manager I 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. The Project Manager I will report to the PharmaDx Group Manager for the PharmaDx Clinical Investigations team. The Project Manager I has a working knowledge of drug development and clinical trial execution and applicable regulatory requirements. The Project Manager I will independently manage projects small to large in scope and complexity. The Project Manager I will create and manage original study documentation including sample analysis plans, IRB regulatory binders, data transfers and study reports, as applicable. The Project Manager I will prepare meeting agendas and minutes for Sponsor and internal project meetings. The Project Manager I 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 :
Manages ARUP projects as defined by the Project Management Policy, including developing and monitoring project timetables, deliverables, project communications and progress reports, and other project requirements.
Follows project management methodologies as defined and outlined by Project Management Institute (PMI) and ARUP policies and procedures.
Creates and executes project work plans and revise as appropriate to meet changing needs and requirements.
Facilitates and troubleshoots problems associated with developing complex systems or with coordination, development, or design of projects.
Identifies resources needed and assign individual responsibilities.
Manages day-to-day operational aspects of projects and their scope.
Manages project budget, including tracking and reporting expenses, capital costs, and resource costs.
Analyzes project profitability, revenue, margins, and utilization.
Establishes and maintains communication as required with the project sponsor and operational committees and management.
Coordinates schedules of staff and other interested parties.
Reviews deliverables prepared by team before passing to client, project sponsor, or stakeholder.
Presents analysis and recommendations to senior management, the Project Management Office, and other groups by request. Maintains open and effective communication with and between personnel on work teams and with other members of the organization.
Ensures that proper processes are being followed and assist in establishing new processes as required.
Reports on project progress to various management groups and committees as requested.
Maintains professional relationships with investigators and sponsors, which may include physicians, medical research staff and outside consultants.
Serves as a liaison between study sponsors, investigative sites, and the clinical research organization.
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.
Working knowledge of FDA and other regulatory requirements.
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.
Qualifications
Education
Required
+ Associates Degree or better in Business
Preferred
+ Bachelor's Degree or better in Business
Licenses & Certifications
Preferred
+ Project Management Prof
Experience
Required
+ Bachelor’s degree in Business Management, Project Management, Medical Laboratory Science, Biology, Chemistry, or equivalent degree and two years of experience managing complex, multi-departmental project(s) Or Associate’s degree plus PMP certification and two years of experience managing complex, multi-departmental project(s) Or Associate’s degree and four years of experience in a support role with project management, project implementation, or project planning
Preferred
+ Two years of experience in research or clinical laboratory setting
+ Two years of managing complex project(s)
+ Experience in quality control and quality assurance
+ Experience with MasterControl document control software
+ Experience drafting and editing SOPs
+ Experience drafting responses to quality audit reports
+ Experience in Good Laboratory Practice environment
+ Management experience of laboratory projects
+ Experience in pharmaceutical development
+ Excellent oral communication skills
+ Excellent written communication skills, as exemplified by a writing example taken during the interview process
+ MBA or MA in Project Management
+ Experience in various software applications including the following: @Task or other Project Management Software, MS Office 2003, including Visio, Word, Excel, and PowerPoint, Computer aided simulation, process modeling software, Accounting, document management, and other enterprise software systems, IT Managers may require additional IT hardware and software experience, depending on the nature of the IT projects managed
+ Demonstrated organizational, problem solving, troubleshooting, and interpersonal skills
+ Demonstrated knowledge of the technical and administrative aspects of all phases of project management, as defined by PMI
+ Clinical trial operation experience
+ 1-2 years of experience in writing study protocols or sample analysis plans and other technical documents
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)
Schedule: Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM
Department: PharmaDx - 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 I -Clinical to manage clinical trial projects for therapeutic drug and CDx programs.
Primary Purpose :
The Project Manager I 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. The Project Manager I will report to the PharmaDx Group Manager for the PharmaDx Clinical Investigations team. The Project Manager I has a working knowledge of drug development and clinical trial execution and applicable regulatory requirements. The Project Manager I will independently manage projects small to large in scope and complexity. The Project Manager I will create and manage original study documentation including sample analysis plans, IRB regulatory binders, data transfers and study reports, as applicable. The Project Manager I will prepare meeting agendas and minutes for Sponsor and internal project meetings. The Project Manager I 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 :
Manages ARUP projects as defined by the Project Management Policy, including developing and monitoring project timetables, deliverables, project communications and progress reports, and other project requirements.
Follows project management methodologies as defined and outlined by Project Management Institute (PMI) and ARUP policies and procedures.
Creates and executes project work plans and revise as appropriate to meet changing needs and requirements.
Facilitates and troubleshoots problems associated with developing complex systems or with coordination, development, or design of projects.
Identifies resources needed and assign individual responsibilities.
Manages day-to-day operational aspects of projects and their scope.
Manages project budget, including tracking and reporting expenses, capital costs, and resource costs.
Analyzes project profitability, revenue, margins, and utilization.
Establishes and maintains communication as required with the project sponsor and operational committees and management.
Coordinates schedules of staff and other interested parties.
Reviews deliverables prepared by team before passing to client, project sponsor, or stakeholder.
Presents analysis and recommendations to senior management, the Project Management Office, and other groups by request. Maintains open and effective communication with and between personnel on work teams and with other members of the organization.
Ensures that proper processes are being followed and assist in establishing new processes as required.
Reports on project progress to various management groups and committees as requested.
Maintains professional relationships with investigators and sponsors, which may include physicians, medical research staff and outside consultants.
Serves as a liaison between study sponsors, investigative sites, and the clinical research organization.
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.
Working knowledge of FDA and other regulatory requirements.
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.
Qualifications
Education
Required
+ Associates Degree or better in Business
Preferred
+ Bachelor's Degree or better in Business
Licenses & Certifications
Preferred
+ Project Management Prof
Experience
Required
+ Bachelor’s degree in Business Management, Project Management, Medical Laboratory Science, Biology, Chemistry, or equivalent degree and two years of experience managing complex, multi-departmental project(s) Or Associate’s degree plus PMP certification and two years of experience managing complex, multi-departmental project(s) Or Associate’s degree and four years of experience in a support role with project management, project implementation, or project planning
Preferred
+ Two years of experience in research or clinical laboratory setting
+ Two years of managing complex project(s)
+ Experience in quality control and quality assurance
+ Experience with MasterControl document control software
+ Experience drafting and editing SOPs
+ Experience drafting responses to quality audit reports
+ Experience in Good Laboratory Practice environment
+ Management experience of laboratory projects
+ Experience in pharmaceutical development
+ Excellent oral communication skills
+ Excellent written communication skills, as exemplified by a writing example taken during the interview process
+ MBA or MA in Project Management
+ Experience in various software applications including the following: @Task or other Project Management Software, MS Office 2003, including Visio, Word, Excel, and PowerPoint, Computer aided simulation, process modeling software, Accounting, document management, and other enterprise software systems, IT Managers may require additional IT hardware and software experience, depending on the nature of the IT projects managed
+ Demonstrated organizational, problem solving, troubleshooting, and interpersonal skills
+ Demonstrated knowledge of the technical and administrative aspects of all phases of project management, as defined by PMI
+ Clinical trial operation experience
+ 1-2 years of experience in writing study protocols or sample analysis plans and other technical documents
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)
Source : ARUP Laboratories