Senior Clinical Project Manager – Global Trials Lead

CTI Clinical Trial and Consulting Services; Wales; Hybrid; GBP 65,000 - 110,000; Full time

Benefits offered by this job

Hybrid work opportunities

Job summary

CTI Clinical Trial and Consulting Services in the United Kingdom seeks an experienced project lead to plan, manage and complete global clinical trials from start-up through analysis. You will direct cross-functional teams, ensure regulatory and GCP compliance, and partner with CTI’s executive team to optimize budgets and timelines.

The role requires a Bachelor’s degree in allied health fields and at least 6 years of clinical research or related project-management experience, with fluency in

Qualifications

• Bachelor's degree in allied health fields such as nursing, pharmacy or health science; 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
• Fluent in English

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 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 elevate 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.
• In the EU, preparation and negotiation of site budgets, site payments and payment of site invoices are handled by the EU Clinical Trial Budget Management Team with the assistance of regional CRAs or Study Start-up Specialists to support country specific language communications.

Skills

Leadership

Project management

Team coordination

Clinical research

Education

Bachelor's degree in allied health fields such as nursing, pharmacy or health science

Job description

CTI Clinical Trial and Consulting Services in the United Kingdom seeks an experienced project lead to plan, manage and complete global clinical trials from start-up through analysis. You will direct cross-functional teams, ensure regulatory and GCP compliance, and partner with CTI’s executive team to optimize budgets and timelines.

The role requires a Bachelor’s degree in allied health fields and at least 6 years of clinical research or related project-management experience, with fluency in