Job description

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 India 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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