Associate Laboratory Project Services Manager
Company: Q2 Solutions
Posted on: October 18, 2020
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
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
- 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
- v. Partner with Study Set-Up team to ensure quality of study
c. Participate in the proposal development process as
d. Participate in the business development processes as applicable
to Project Services responsibilities.
e. Lead in the development of sponsor specific standards and/or
f. Ensure key milestones are met and appropriate resources are
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
h. Support the development of sponsor specific standards and/or
Study Activity Monitoring and Closeout
a. Monitor Project Management Plan, timelines, and deliverables,
including trend analysis of study specific data, budget and change
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
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 meetings, etc.).
d. Lead problem solving and resolution efforts in a timely,
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
- 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
- Coordinate meeting agenda, document minutes, track actions, and
provide status updates.
- 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.
- 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
- Represent the company at Investigator/ Monitor meetings,
internal and external authorities of regulatory bodies, and other
Face to face meetings.
- Participate in external and internal audits/inspections as
- 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.
- 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
- Demonstrated computer proficiency with Microsoft Office and the
company systems, or equivalent experience with similar Centralized
Laboratory systems preferred
- Experience in successfully leading Phase I-IV clinical trials
- Demonstrated ability to work in a fast-paced while possessing
strong organizational skills and a demonstrated ability to meet
- 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
- Ability to establish and maintain effective working
relationships with coworkers, managers and clients.
- Bachelor's degree in Life Sciences or related field with 2-3
years of experience in clinical trials/ hospital-funded research,
project management or laboratory environment preferred; equivalent
combination of education, training and experience
IQVIA is an EEO Employer - Minorities/Females/Protected
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 email@example.com to arrange for such an
Keywords: Q2 Solutions, Durham , Associate Laboratory Project Services Manager, Executive , Durham, North Carolina
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