Precision Medicine Group palīdz farmācijas un dzīvības zinātņu organizācijām izstrādāt un komercializēt produktus, apvienojot precīzijas medicīnas, laboratorijas zinātnes, translācijas informātikas, regulatīvo jautājumu, maksātāju izpētes un mārketinga komunikācijas kompetenci. Tās darbība aptver biomarķieru pētījumus un izstrādi, klīnisko un komerciālo stratēģiju, kā arī atbalstu visā produkta dzīves ciklā — no laišanas tirgū līdz brieduma posmam. Uzņēmums darbojas ar Precision for Medicine, kas koncentrējas uz klīniskajiem risinājumiem, un Precision AQ, kas dzīvības zinātņu nozares klientiem nodrošina komerciālus risinājumus.
Senior Clinical Trial Manager, Latin America
Lead clinical study planning, site operations, and compliance across Latin America. Support Precision Medicine Group’s clinical operations in Brazil, Colombia, and Mexico.
Apraksts
- Serve as the lead clinical contact for clients.
- Plan, execute, and oversee clinical studies in line with protocols, SOPs, ICH-GCP, and regulatory requirements.
- Work with the Project Manager on monthly invoicing and clinical budget variance tracking.
- Prepare clinical plans, informed consent templates, study forms and manuals, CRF completion guidance, trackers, PSV/SIV slides, and training materials.
- Identify training needs for CRAs and third-party vendors, and deliver training at Investigator Meetings and study kick-off meetings.
- Build potential site lists and lead site feasibility work.
- Assess enrollment risks and develop country-level recruitment and retention strategies.
- Coordinate feasibility, site start-up, enrollment, study maintenance, and close-out.
- Lead internal clinical team meetings and set expectations for CRAs and CTAs.
- Respond to CRA and site questions and maintain the FAQ log.
- Help plan and conduct investigator meetings.
- Review or approve investigational product release packages.
- Oversee submissions and approvals with Competent Authorities and IRB/Ethics Committees.
- Develop clinical monitoring strategies and keep study timelines and quality deliverables on track.
- Create and use metrics reports covering CTMS, data-management query trends, and overdue monitoring reports.
- Implement and manage the eTMF.
- Develop and implement CAPA plans with the PM, CRAs, and QA.
- Help sites, internal staff, and CRAs prepare for GCP audits.
- Coordinate project-specific resourcing needs with the PM.
- Escalate CRA performance concerns and site compliance issues.
- Work with data management and CRAs to maintain data quality and meet data-cleaning timelines.
- Manage investigational product processes, including drug accountability and reconciliation.
- Take on project management duties when no cross-functional PM is assigned.
- Support business development and marketing activities.
- Negotiate site budgets and investigator contracts as needed.
- Review site visit reports and confirm monitoring follows the monitoring plan.
- Manage clinical vendors as needed.
- Review clinical data in patient profiles, data listings, and summary tables, including generating queries.
- May manage direct reports.
- Carry out other duties assigned by management.
Prasības
- Bachelor’s degree, or an equivalent combination of education and experience, in a science or health-related field; an advanced degree is preferred.
- At least 7 years of clinical research experience, or demonstrated competencies for the role, including substantial clinical monitoring experience.
- Professional working proficiency in English.
- Experience with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
- Ability to travel domestically and internationally, including overnight trips.
- Strong command of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with the ability to apply them.
- Working knowledge of clinical management methods and tools.
- Direct experience working in a cross-functional environment.
- Demonstrated experience in functional management, delegation, planning, risk management, and change management.
- In-depth experience in pharmaceutical and/or medical device research.
- Demonstrated ability to negotiate independently and manage conflict.
- Strong communication, organization, presentation, analytical, interpersonal, time-management, decision-making, and critical-thinking skills.
Priekšrocības
- Career development opportunities, including building teams, defining processes, shaping culture, and taking on broader leadership or project management responsibilities.
- Regular full-time employment.