Clinical Project Manager Iii/ Senior Cpm (Level Dependent On Experience)

Cti; Viseu; Híbrido; EUR 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work opportunities

Resumo da oferta

CTI is seeking a Clinical Project Manager with strong leadership to oversee global clinical trials from start-up to analysis. The role requires coordinating functional areas to ensure ICH and GCP compliance, overseeing budgets, timelines, and deliverables, and guiding cross-functional teams through multiple simultaneous projects.

The ideal candidate will have a minimum of 6 years in clinical research, fluency in English, and a background in allied health fields.

Qualificações

• 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 transferable skills in project management in a clinical setting or relatable industry.
• Fluent in English

Responsabilidades

• Plan, implement, evaluate, and complete full 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, GCP and trial procedures.
• Manage full-scope clinical trial projects including global trials from start-up through analysis phase.
• Coordinate and oversee team members on clinical trials projects and manage multiple projects simultaneously.
• Prepare or provide oversight to the development of trial plans, timelines, budgets, and deliverables.
• Lead client and team meetings to enable effective info sharing, discussion, and decision making.

Conhecimentos

Fluent English

Formação académica

Bachelor's degree in allied health fields

Descrição da oferta de emprego

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 oversightof 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 changeof scope orders when appropriate.

Prepare or provide oversight and support to the development of trial plans, timelines, schedules, 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 contractedspecifications 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 oversightof the CRA's management of sites and monitoring of the clinical trial data;

review and approve sitetrip 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 info sharing, discussion, and decision making;

ensure accurate and complete documentation of the meeting discussions, decisions and outcomes.

Prepare or give 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.). Suggested, 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 Start-up Specialists to support country specific language communications.

What You'll Bring:

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 About CTI

Advance Your Career We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals. Join an Award‑Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work‑life balance with hybrid work opportunities. Through our CTI Cares program, you'll have opportunities to give back to your community and the world. Make a Lasting Impact At CTI, your work directly contributes to advancing medicine. You'll play a vital role in developing life‑changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Clinical Project Manager Iii/ Senior Cpm (Level Dependent On Experience) Piedade, Portuguese Republic, PT