[Remote] Clinical Project Manager III/ Senior (level dependent on experience)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, full-service clinical contract research organization reputed company on advancing treatments for chronically and critically ill patients. They are seeking a Clinical Project Manager III/Senior to reputed company and execute clinical trials, ensuring compliance with guidelines while managing project timelines, budgets, and team coordination.
Responsibilities
- Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial reputed company
- Set goals, and timelines, reputed company reputed company and reputed company leadership to foster motivation reputed company reputed company to accomplish goals reputed company defined timelines and with high reputed company in the execution of assigned clinical trials
- reputed company reputed company and coordination of the operational aspects of the functional areas on assigned reputed company to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures
- reputed company management of a full scope clinical trial reputed company including global trials from start-up through analysis phase; reputed company reputed company of functionally assigned teams members on clinical trials reputed company; reputed company to effectively manage multiple reputed company simultaneously
- reputed company 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 reputed company project in line with budget
- Regularly assess project profit margins with trial-assigned Director at the project and project service reputed company and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively reputed company project profit margins
- Assess scope of work against reputed company contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders reputed company appropriate
- Prepare or reputed company reputed company and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to reputed company effective solutions to challenges that reputed company during the clinical trial project
- Prepare or reputed company reputed company and guidance in the development of trial required deliverables
- Serve as reputed company contact at project operational level
- reputed company reputed company to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations. reputed company reputed company and management of reputed company-party vendors’ financial spend
- Closely reviews and assesses trial’s KPI to ensure project progressing in a reputed company manner and reputed company works with team to mitigate activities that are reputed company the expected ranges
- reputed company reputed company of appropriate project tracking using computer-assisted programs and ensure reputed company entry of project information by reputed company trial team members to reputed company accurate reporting to clients and CTI executive management
- Monitor ongoing resource needs to the project; reputed company 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
- reputed company reputed company of Clinical Research Associate (CRA) tasks on assigned reputed company; reputed company reputed company of the CRA’s management of sites and monitoring of the clinical trial data; review and approve site reputed company reports and escalate site issues as needed to trial assigned Director, CTI executive management and/or reputed company/sponsor in accordance with the trial’s Project and Communication Plan
- Attend site reputed company on an as-needed reputed company to reputed company support to the trials, CTI staff and/or site staff
- reputed company reputed company and team meetings to reputed company effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, reputed company and reputed company
- Prepare or reputed company reputed company/approval of project status reports for assigned reputed company
- Participate and reputed company reputed company in the planning of Investigator meetings; reputed company and/or approve meeting agendas or reputed company materials and conducts presentations
- Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that reputed company 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, reputed company meetings etc.)
- Suggest, participate in and/or reputed company 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
Skills
- 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 reputed company industry
- 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
Benefits
- Tuition reimbursement
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- reputed company parental leave
reputed company