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1 Vacancy
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Job Location drjobs

Ahmedabad - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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 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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Required Experience:

Manager

Employment Type

Full-Time

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