Provide day-to-day direction of staff and manage the Client Delivery Team to achieve client and company goals and/or initiatives; Support direct reports and drive continuous improvement in processes and procedures used by the project team; Perform duties and responsibilities of Project Manager/Set Up Project Manager when needed, for short-term or long-term assignments.
location: Morrisville, North Carolina
job type: Permanent
salary: $100,000 - 120,000 per year
work hours: 9 to 5
This position involves extensive mentoring and professional development of direct staff within the Customer Delivery Teams:
- 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, 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.
- Consult and advise customer 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. v. Partner with Study Set-Up team to ensure quality of study set-up.
- Participate in the proposal development process as applicable.
- Participate in the business development processes as applicable to Project Services responsibilities.
- Lead in the development of sponsor specific standards and/or program-specific procedures.
- 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.
- Support the development of sponsor specific standards and/or program-specific procedures.
- Study Activity Monitoring and Closeout
- Monitor Project Management Plan, timelines, and deliverables, including trend analysis of study specific data, budget and change orders.
- 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.).
- 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.
- 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 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 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.
- 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.
- Bachelor's Degree Life Sciences and/or related field preferred
- 1-3 years of experience in clinical trials/ hospital-funded research, project management or laboratory environment preferred.
- Equivalent combination of education, training and experience required
- Strong interpersonal and client management skills
- Working understanding of medical and clinical research terminology.
- 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.
- 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 preferred.
- Demonstrated ability to work in a fast-paced while possessing strong organizational skills and a demonstrated ability to meet deadlines.
- 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 establish and maintain effective working relationships with coworkers, managers and clients.
skills: GLP (Good Laboratory Practice), GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.