Associate Laboratory Project Services Manager (R1110340)

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.

PURPOSE

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 customer, drug program, indication or drug compound; participate in business

development process consistent with Project Services responsibilities; serve as a point of escalation for program level issues,

while ensuring consistency of delivery on a global level; and manage individual clinical trial projects as assigned.

RESPONSIBILITIES

. 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. Lead problem solving and resolution efforts in a

timely, customer focused manner.

. Serve as a liaison between Sponsor and QLAB project teams.

. Participate in proposal development process, as well as, lead bid defense presentations in partnership with Business

Development and Senior Project Services/Operational Client Lead staff. Perform the technical review at program / project

initiation and provide input into project proposals as well as lead discussions around budget implications and changes.

. Lead in the development of sponsor specific standards and program-specific procedures.

. Collaborate with other functional groups within the company where necessary to support milestone achievement and to

manage study issues and obstacles.

. 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.

. Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of

protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory

specifications document for each protocol within a program as appropriate.

. 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 external and internal audits as required.

. Direct, mentor and assist in training of less experienced Project Services staff. Mentoring may include staff assigned to

manage projects for the specific client or within the program. Report on team performance against contract, customer

expectations, and project baselines to management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

. Possess strong interpersonal skills for interaction with senior members within sponsor organizations

. Demonstrated ability to meet deadlines.

. Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system. .

. Possess an understanding of medical and clinical research terminology.

. Demonstrated ability to work in a fast-paced, high stress environment.

. Knowledge of Project Management processes and terminology.

. Previous knowledge of Quintiles Laboratories processes and computer systems is highly desired.

. Good organizational and operational skills

. Good accuracy and attention to detail skills

. Strong written and verbal communication skills including good command of English language

. Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

. Bachelor's degree in science related field and minimum 3 years of clinical or research industry experience, including 1

year project management experience; or equivalent combination of education, training and experience