Acts as the subject matter expert for country or regional clinical trial operations, and supports country or regional corporate operations functions as necessary (human resources, finance, IT, legal). Responsible for the planning, start-up and management of clinical trials within a defined country or region, in collaboration with the global project team. Acts as the key liaison with country or regional Investigators, vendors and thought leaders.
Country or Regional Operations (30%)
- · Develops and maintains professional relationships with country or regional key Investigators and and thought leaders
- · Collects and provides country/region insights on GI healthcare processes and drug coverage for GI diseases
- · Acts as vendor lead and oversees country or regional vendors (e.g. local supply depot)
- · Leads general or study specific site qualification, feasibility, and selection activities in collaboration with the global team
- · Supports corporate operations functions as required (finance, HR, IT, legal)
- · Lead country regulatory gap assessment to ensure Alimentiv processes are in compliance with local requirements
- · Acts as Alimentiv’s spokesperson in the country/region
People Operations (50%)
- Responsible for country or regional oversight of all trial activities to ensure projects are delivered in Leads country or regional regulatory and/or ethics submissions for clinical trials
- Leads import/export processes for clinical trial materials, including investigational product(s), devices, biological samples, laboratory kits and other materials.
- Accordance with the scope of work, and ensure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.
- Perform vendor management oversight as required per project
- Support CRA oversight, assessment and/or training as required.
- Contribute to financial project management processes. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
- May provide direct oversight of investigator sites, including CRA responsibilities, from time to time.
Communications (20%)
- Lead and/or attend meetings with Study Sponsor
- May take part in or lead departmental/company improvement initiatives, committees, working streams and governances.
Qualifications
- Minimum of a Bachelor's Degree (Health Sciences, Clinical Research preferred) with 10 years of progressive experience in Clinical Research
- Demonstrated experience leading all aspects of phase 1-3 trials in the country or region is required
- Strong track record of managing clinical trials and operational activities within Brazil across multiple phases and therapeutic areas
- Previous leadership experience overseeing cross-functional teams
- In-depth knowledge of country-specific clinical research regulations, Good Clinical Practice (GCP) guidelines, and local ethics committees
- Proven experience in planning, budgeting, and resource allocation
- Successful track record of delivering on timelines and budgets in a fast-paced, dynamic environment.
Working Conditions
- Home Based
- Occasional travel (Domestic and International)
Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com
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Last updated on Dec 24, 2024