Senior Project Manager

Lambda Therapeutic Research is a full- service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), Lambda offer comprehensive end-to end clinical research services to the global innovator, biotech and generic pharmaceutical industries.

Project Manager (Start-up in clinical trial).

1. Coordination with Start Up lead, CTM- Lead, CTM PMs for site identification for awarded study.
2. Preparation of Investigator site budget for study quote preparation & finalize same in consultation with Start Up lead & CTM Lead
3. Ensure executed MSA/quote update in CTMS before any study related activity initiate
4. Finalization of Feasibility Questionnaire for a study specific feasibility based on the finalised study protocol in consultation with CTM Lead & Medical monitor.
5. Finalization of sites for the FQ collection in consultation with Start Up lead, CTM- Lead
6. Review & finalise study specific templates i.e. IU, PSP, FDA forms etc.
7. Coordination with vendors for study instruments requirement & ensure availability of same before sites initiation.
8. Support the regulatory team in completing the DCGI dossier (site documents collection) for regulatory submission. And resolve query of Regulatory Authority team.
9. Site budget negotiation with sites per MSA with sponsor and oversee CTA execution with sites.
10. Coordination for with sites for EC related activities.
11. Oversee CTMS is updated on regular basis with new identified investigators & sites.
12. Ensure IMP release review/SIV clearance before SIV execution.
13. Coordination with vendors, internal stake holders for start up activities.
14. Any other responsibilities as assigned by the Management/ HOD.

Feasibility questionnaire preparation and finalization

Site identification and selection,

Clinical study initiation

Site budgets finalization

Coordination with various stake holders for site finalization and initiation.

At least 8-10 years experience in clinical trial preferably in startup- division

MSc, Mpharm, Bpharm, BAMS, BHMS, Dentist or similar from medical science background