Job Overview:

Job Summary:

Oversees and manages domestic, regional and/or international clinical trials conducted at Labcorp Clinical research sites, external sites, and data services projects. Projects generally include full service including multiple moderately complex trials managing multiple vendors and external sites for trials of moderate to high financial value, and may consist of serving in a program oversight role. Primary client contact and responsible for the facilitation of communication, managing client expectations, and build ing business relationships.

Responsibilities typically include:

- managing scope of project and project components, budgets, timelines, and quality guidelines thereby ensuring that expectations are met while identifying and mitigating risks. Responsible for managing the project team in a matrix environment.

- May also contribute to strategic relationships by monitoring and reporting Key Performance Indicators (KPI), and may assist in the development of KPI. Using detailed knowledge of clinical development, may lead bid defense and other business development activities.

- Works independently to lead a project team or under the direction of a more senior Project Manager on a program of studies, while adhering to professional, SOP, regulato1y and ICH/GCP standards.

- Assesses resource needs for project or program delivety based on scope of services to be provided.

- Manages and communicates scope of the project according to proposal, budget, timeline throughout the life cycle of the project. Works with project team on identification of work scope changes against the project timelines.

- Creates and/or review required project plans. Implement and monitor progress against project.

- Plans and timelines and revise as necessaiy. Ensure consistency of plans across programs.

- Organizes, chairs, and ensures accurate documentation in meeting minutes for project meetings with client and team, as applicable. Completes, or delegates with oversight, the Project Log (Action/Decision/Issues) items to ensure appropriate project team member delegation and resolution.

- Performs overall management of the project timelines through use of MS Project ensuring that changes or updates are made and communicated in a timely manner. Renegotiates timelines with client and project team as necessary.

- Develop a thorough understanding of clinical, biometrics and critical path activities.

- Proactively engages in both quality assurance and risk management and mitigation activities to ensure project deliverables are met according to both Labcorp and client requirements, ensuring appropriate escalation of risks to all stakeholders.

- Manages and communicates scope of the project according to proposals, budgets and ongoing project progress. Works with project team in identifying, initiating work scope changes, tracking and delivering to the client.

- Responsible for the review and assessment of ongoing hour/budget utilization throughout the course of project to ensure that the projects are meeting financial targets.

- Supports negotiations with client to ensure budget remains within contracted terms. Controls project margins and minimizes write offs by working with key stake holders and senior leadership.

- Collaborates with finance when project milestones or completion of contracted units of activity have been met to approve monthly invoicing, and performs client follow up as appropriate.

- Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client.

- May oversee timely uploading of documents by the project team into the TMF for client held systems.

- Accountable for directing the CTMS build, working with project team to ensure loading of information for site activation and timely entry of key milestones for site payment.

- Accountable for developing Project Specific Training and ensuring project team members ave read, reviewed and documented project related documents and plans.

- Drives issue resolution at the project and program level. Ensures proper escalation of potential CQI per Covance SOPs.

- Contributes to audit responses from agencies and clients, as appropriate.

- Ensures lessons learned are implemented across projects currently being managed and across the depaiiment as applicable.

- Initiates and drives improvements to enhance the efficiency and the quality of the work performed on assigned projects.

- Assist in the repotiing of strategic client metrics.

- Contributes to proposal strategy, development, and lead bid defense strategy for assigned business development opportunities.

- May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Managers.

- Increase potential for repeat business by establishing a strong working relationship with the client project team striving for client satisfaction and operational excellence.

- Perform other duties as assigned by management.

Site Management:

- Responsible for the oversight of site start up activities.

- Oversees the coordination of the study activation components of the project from an oversight level including Feasibility, Site selection, Activation, Site Contracting, Regulatory Submission, Greenlight.

- Assists in the design and maintenance of tools/ processes relevant to feasibility assessments and patient recruitment campaigns.

- Supervision of Investigator package review and approval prior to drug shipment.

- Supervision of study set-up with the clients regarding pre-study documentation for Investigator packages.

- Supervision of Site Budget and Statements of Agreement (SoA) documents that leads to an executed site contract.

- Supervision of Document Review, including Informed Consent Forms, Advetiisements, labels and protocols.

Education/Qualifications:

- University/college degree (life science preferred) or certification in a related allied health

- profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.

- Acceptable: In lieu of the above requirement, candidates with a 2-year Associate Degree and additional 5 or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.

Strongly Preferred:

- Ability to communicate freely using spoken and written Mandarin (Chinese) Langauage at a business level

Experience:

- Clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.

- Acceptable: In lieu of above experience requirement, a combination of other experiences including, but not limited to preclinical research, biometrics clinical supervision, clinical study management, clinical monitoring, and clinical project management may be considered.

- Experience in managing projects in a vittual environment.

- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.

- Financial awareness and ability to track project progress against financial milestones.

- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.

- Demonstrated ability to lead by example and to encourage team members to seek solutions.

- Excellent communication, planning and organizational skills.

- Ability to work independently.

- Ability to negotiate and liaise with clients in a professional manner.

- Ability to present to staff at all levels.

- Good computer skills with good working knowledge of a range of software packages.

- Detailed knowledge of project management processes.