Lab Project Services Manager / Senior Lab Project Services Manager (Home Based)
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
Under general direction, manage all laboratory aspects of clinical trial projects for a client, either global and or regional studies; serve as a point of escalation for project level issues, while ensuring consistency of delivery on a global level; and participate in business development process consistent as required.
- Perform project management of laboratory aspect of assigned studies.
- Develop start-up plans including but not limited to 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.
- Establish self as key client relationship contact, including tasks such as coordinating client surveys and follow up actions, making periodic “health check” calls, and identifying any potential issues to the relevant mangers
- 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 project initiation and provide input into project proposals as well as lead discussions around budget implications and changes.
- Provide scientific and technical advice to ensure delivery to the customer’s satisfaction, on time and within budget.
- 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, as well as the proactive development of 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 assigned protocol.
- 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.
- Provide day to day guidance to more junior staff as required; may act as a mentor as well as assist in the training and development of more junior staff.
- 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Possess strong interpersonal skills for interaction with senior members within sponsor organizations and demonstrated ability to meet deadlines.
- Experience in successfully leading Phase I-IV clinical trials.
- Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.
- 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in science related field and minimum 5 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- May require occasional travel
EEO Minorities/Females/Protected Veterans/Disabled
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