Laboratory Project Services Manager
Position can be located in Valencia, CA or Collegeville, PA
As lead Global Project Manager or Regional PM, manage internal laboratory teams to ensure successful delivery of all study activities. Act as main point of contact for clients post study award and throughout the entire study lifecycle (startup, maintenance, close-out).
Study Setup and Planning
- Manage individual clinical trial projects as assigned.
- Facilitate Seamless Study Set-Up
- Review study protocol and bid/budget information once a study is awarded.
- Ensure initial meetings are conducted (e.g. document review meetings, Design, or Startup meetings) with sponsor, Protocol requirements are understood and applied to the design of the lab study, and relay lab processes to the client.
- Consult and advise client on best or most proper course of action as needed.
- Develop, relay and implement the Project Management Plan and Risk Management Plan per study as applicable; Create cost containment measures.
- Partner with Study Set-Up team to ensure quality of study set-up.
- Participate in proposal and the business development processes as applicable to Project Services responsibilities.
- Perform the technical review at program / project initiation and provide input into project proposals as well as lead discussions around budget implications and changes
- Ensure key milestones are met and appropriate resources are available.
- 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.
Study Activity Monitoring and Closeout
- Monitor Project Management Plan, timelines, and deliverables, including trend analysis of study specific data.
- Manage study scope changes and study budget.
- Utilize available tools, metrics, and reports as part of global study monitoring and closeout.
- Manage all service related issues and implement changes to plan as required.
- Conduct meetings with internal departments as required to meet needs of study and closeout activities.
- Monitor quality of study and proactively determine and implement solutions for any issues that arise.
- Report study progress to internal and external clients.
- Ensure lessons learned are considered, shared and improvements included in processes, as applicable.
Proactive lines of communication
- Build and own client relationship for assigned study and serve as a liaison between Sponsor and project teams.
- Facilitate Communication with the Client.
- Act as the single point of contact for client, both responding and triaging communications.
- Lead and/or participate in key client facing meetings (investigator meetings, study meetings, etc.).
- Travel and present lab services at client meetings; provide support to sales for bid defenses and capabilities presentations.
- Coordinate customer survey follow-up/ongoing health check calls and overall client relationship building.
- Lead problem solving and resolution efforts in a timely, client-focused manner.
- Serve as a liaison between Sponsor and project teams; Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Serve as a point of escalation for program level issues, while ensuring consistency of delivery on a global level.
- Coordinate and Triage Study-specific issues.
- 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.
- Escalate issues that impact the study plan or budget and relay any issues or trends to clients as applicable.
- 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 Q2 Solutions 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 required.
- 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.
- Report on team performance against contract, client expectations, and project baselines to management.
- All Project Managers 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.
- 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.
- Provide day to day mentoring and guidance to new hires and more junior staff as required.
- Provide coaching and guidance through teaching, counseling, advising, and supporting Project Coordinators.
- Conduct regular meetings with Project Coordinators to discuss objectives, key issues, and deliverables.
- Provide input and feedback to Team Managers regarding Project Coordinator performance.
Process Improvements and Special Assignments
- Participate in Process Improvement Initiatives (e.g. Ho-Shin Strategy Initiatives, etc.), as applicable.
- Assist Line Manager with special assignments for the department as needed.
- Take the lead as assigned task owner and/or Subject Matter Expert, ‘SME’, for the department as requested.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent interpersonal and client management skills.
- Thorough knowledge of Project Management processes, Q2 Solutions 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.
- Demonstrated computer proficiency with Microsoft Office and Q2 Solutions systems, or equivalent experience with similar Centralized Laboratory systems preferred.
- Experience in successfully leading Phase I-IV clinical trials preferred.
- Demonstrated ability to work in a fast-paced while possessing strong organizational skills and an ability to meet deadlines.
- Strong written/verbal communication skills including good command of English language. In certain geographies where local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s degree in Life Sciences and/or related experience preferred.
- 3-5 years of experience in clinical trials/ hospital-funded research, project management or laboratory environment preferred.
Position can be located in Valencia, CA or Collegeville, PA
- 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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