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 startup 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 Alimentivs 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 passthrough 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 Bachelors Degree (Health Sciences Clinical Research preferred) with 10 years of progressive experience in Clinical Research
Demonstrated experience leading all aspects of phase 13 trials in the country or region is required
Strong track record of managing clinical trials and operational activities within India across multiple phases and therapeutic areas
Previous leadership experience overseeing crossfunctional teams
Indepth knowledge of countryspecific 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 fastpaced 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
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