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CTI Clinical Trial and Consulting Services · 17 hours ago

Clinical Project Manager III/ Senior (level dependent on experience)

Covington, KY

Full-time

Hybrid

Senior Level

6+ years exp

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on the advancement of treatments for chronically and critically ill patient populations. The Clinical Project Manager III is responsible for the execution and oversight of assigned clinical trials to ensure client goals of time, cost, and quality performance are met, while often functioning as a global lead.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

Responsibilities

Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead

Set goals, and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials

Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures

Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously

Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities

Implement project activities according to scope of contracted work

Evaluate and manage project budget against project milestones and scope and collaborate with the trial assigned Director as needed to take corrective measures where necessary to keep project in line with budget

Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins

Assess scope of work against client contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders when appropriate

Prepare or provide oversight and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to provide effective solutions to challenges that arise during the clinical trial project

Prepare or provide oversight and guidance in the development of trial required deliverables

Serve as client contact at project operational level

Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations. Provide oversight and management of third-party vendors’ financial spend

Closely reviews and assesses trial’s KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges

Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management

Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues

Ensure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol

Provide oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA’s management of sites and monitoring of the clinical trial data; review and approve site trip reports and escalate site issues as needed to trial assigned Director, CTI executive management and/or client/sponsor in accordance with the trial’s Project and Communication Plan

Attend site visits on an as-needed basis to provide support to the trials, CTI staff and/or site staff

Lead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes

Prepare or provide oversight/approval of project status reports for assigned projects

Participate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentations

Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial’s TMF Plan

Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)

Suggest, participate in and/or lead process improvement activities and initiatives

Mentor other CPM staff

As required per region, review site and vendor invoices, approve subject milestones payments per scope; assist in the preparation of payment projections, and in the maintenance of payment records per regional needs. Support or conduct site budget negotiation for sites in their region as needed

Qualification

Clinical trial managementRegulatory complianceProject managementClinical research experienceMedical terminology knowledgeBudget managementVendor managementLeadershipTeam collaborationMentoring

Required

Bachelor's degree in allied health fields such as nursing, pharmacy, health or natural sciences, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience

At least 6 years of clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry

Preferred

Graduate degree preferred

Previous technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CRO

Previous CRA experience preferred

Experience or education indicating knowledge of medical and pharmaceutical terminology preferred

Previous experience in a Clinical Project Manager or Clinical Trial Manager level position preferred