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Laboratory Project Services Manager

Job description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Family Description
Develops, plans, manages and reports on laboratory projects and project progress or developments and ensures outcomes are
aligned with client expectations.
Sub-Family Description
Manages the delivery of clinical research studies from initiation to closeout.
Ensures quality deliverables are presented on time and within budget; coordinates work streams and efforts of cross-functional
project teams; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of
contact with the project sponsor.
JOB OVERVIEW
Job Profile Summary
Under general direction, manage all laboratory aspects of clinical trial projects for a client or
a specific program for a client; May have responsibility for a specific client, drug program,
indication or drug compound; Act as main point of contact for the client after study award
and throughout the entire study lifecycle (startup, maintenance, closeout). Role
encompasses Project Lab Services Manager and Associate Lab Services Project Manager
Responsibilities
Essential Functions
• Study Setup and Planning a. Manage individual clinical trial projects as assigned. b. Facilitate Seamless Study Set-Up: i.
Review study protocol and bid/budget information once a study is awarded. ii. Ensure initial meetings are conducted (e.g.
document review meetings, Design, and/or Startup meetings) with sponsor to ensure client Protocol requirements are
understood and applied to the design of the lab study as well as to relay lab processes to the client. iii. Consult and advise
customer on best or most proper course of action as needed. iv. Develop, relay and implement the Project Management Plan
and Risk Management Plan per study as applicable; Create cost containment measures. v. Partner with Study Set-Up team to
ensure quality of study set-up. c. Participate in the proposal development process as applicable. d. Participate in the business
development processes as applicable to Project Services responsibilities. e. Lead in the development of sponsor specific
standards and/or program-specific procedures. f. Ensure key milestones are met and appropriate resources are available. g.
Oversee the writing of protocol-specific laboratory instructional materials (e.g. manuals, flowcharts, etc.) and participate in the
preparation and maintenance of the laboratory specification documents. h. Support the development of sponsor specific
standards and/or program-specific procedures.
• Study Activity Monitoring and Closeout a. Monitor Project Management Plan, timelines, and deliverables, including trend
analysis of study specific data, budget and change orders. b. Manage study scope changes and study budget. c. Utilize
available tools, metrics, and reports as part of global study monitoring and closeout. d. Manage all service related issues and
implement changes to plan as required. e. Conduct meetings with internal departments as required to meet needs of study
and closeout activities. f. Monitor quality of study and proactively determine and implement solutions for any issues that arise.
g. Report study progress to internal and external clients. h. Ensure lessons learned are considered, shared and improvements
included in processes as applicable.
• Proactive lines of communication a. Build and own client relationship for assigned study and serve as a liaison between
Sponsor and project teams. b. Facilitate Communication with the Client. i. Act as the single point of contact for client, both
responding and triaging communications. ii. Lead and/or participate in key client facing meetings (investigator meetings, study
Responsibilities
Essential Functions
meetings, etc.). c. Coordinate customer survey follow-up / ongoing health check calls and overall client relationship building.
d. Lead problem solving and resolution efforts in a timely, client-focused manner. e. Collaborate with other functional groups
within the company where necessary to support milestone achievement and to manage study issues and obstacles. f. Serve
as a point of escalation for program level issues, while ensuring consistency of delivery on a global level. g. Coordinate and
Triage Study-specific issues.
i. Lead in the identification and resolution of service level issues and where issues affect other projects within and across
programs to ensure that any solution is employed universally. Develop proactive contingency plans to mitigate laboratory risk.
ii. Escalate issues that impact the study plan or budget and relay any issues or trends to clients as applicable. iii. Facilitate
regular review meetings to discuss proactive problem resolution of study specific issues, utilizing the necessary resources
from all relevant internal departments.
• Project Documentation and Deliverables a. Coordinate meeting agenda, document minutes, track actions, and provide status
updates. b. Oversee the writing of protocol-specific laboratory instructional documents (e.g. manuals, flowcharts) and
participate in the preparation and maintenance of the laboratory specifications document for each assigned protocol. c.
Develop start-up plans including but not limited to a program/project monitoring and communication plan, including tracking of
milestones and timelines, risk management and action logs. As required, prepare and present study-specific materials and
services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel
as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).
• Participate in Investigator Meetings and Training Activities a. Represent the company at Investigator/ Monitor meetings,
internal and external authorities of regulatory bodies, and other Face to face meetings. b. Participate in external and internal
audits/inspections as required. c. As needed, administer study training to sites, CRA and sponsors and establish regular lines
of communication with sites to manage on-going project expectations and issues. d. All associates will be familiar with the
safety, environmental rules and procedures applying to their job and take reasonable care for their own safety and that of
other people.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
Experience
Typically requires 2 - 3 years of prior relevant experience.
Knowledge
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced
education combined with experience.
Education
Education Level Education Details Req Pref
Bachelor's Degree Life Sciences and/or related field preferred X
Additional Work Experience
Experience Details Req Pref
1-3 years of experience in clinical trials/ hospital-funded research, project management or laboratory
environment preferred. X Or
Equivalent combination of education, training and experience X
Skills and Abilities
Skill/Ability Description Proficiency
Effective interpersonal skills Strong interpersonal and client management skills
Possesses strong product knowledge Working understanding of medical and clinical
research terminology.
Project Demonstrated project management skills Working knowledge of Project Management
processes, the company laboratory processes, and/or
equivalent working knowledge of central laboratory
operations (kits/supplies, logistics, laboratory
operations, specimen storage, data reporting and
transfers, site alerts, etc.) preferred.
Possesses strong technical aptitude Demonstrated computer proficiency with Microsoft
Office and the company systems, or equivalent
Skills and Abilities
Skill/Ability Description Proficiency
experience with similar Centralized Laboratory
systems preferred.
Possesses strong product knowledge Experience in successfully leading Phase I-IV clinical
trials preferred.
Maintains composure under pressure Demonstrated ability to work in a fast-paced while
possessing strong organizational skills and a
demonstrated ability to meet deadlines.
Strong verbal communication and listening skills Strong written and verbal communication skills
including good command of English language. In
certain geographies where communication in local
language is desired (e.g. Japan, China), excellent
command of local language with reasonable
proficiency in English preferred.
Ability to build strong customer relationships Ability to establish and maintain effective working
relationships with coworkers, managers and clients.
Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the
essential functions
Standard ADA Selection Office Environment
Physical Demands
Physical Demand N/A Rarely Occasionally Frequently Constantly
Sit at a desk or table with some
walking, standing, bending, stooping,
or carrying of light objects.
X
Use hands and fingers to handle and
manipulate objects and/or operate
equipment.
X
Working Environment
While performing the duties of this job, the associate is required to meet the following physical demands:
Working Condition N/A Yes No
Working Indoors X
Use of Office Equipment (computer,
printer, telephone, etc.) X
Travel Requirements
Frequency Brief Description
May require occasional travel

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

Laboratory Project Services Manager

Santa Clarita, CA
Full Time

Published on 10/18/2020