Project Manager, Randstad

Randstad

Location:
India, Mumbai

Category:
Health and Beauty

Contract Type:
Employment contract

Salary:

Not provided

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Job Description:

We have an opportunity for Project Manager - Pharmacovigilance with an IIT Bombay incubated company, which is a pioneer in the field of cell & gene therapy. It has developed India’s first and fully indigenously developed CAR-T therapy for the treatment of refractory/relapsing B-cell malignancies (NexCAR19) and has an aggressive pipeline to treat liquid and solid tumors.

Job Responsibility:

To build a good understanding of the Indian oncology space, cancer-site-specific patient burdens, operational details of the CART treatment and patient requirements
To maintain and expand on partnerships with clinical team members of treatment centers, their administration, and auxiliary personnel – with the goal of providing expanded access to CAR-T therapies to patients and ensuring smooth clinical operations
Maintain awareness of current state of cell & gene therapy (literature and competitive intelligence) and provide critical evaluations on the clinical operations
Build and lead a team of executives for each of the current hospitals in their zone
Lead and coordinate internal and external PV audits and inspections
Monitor PV system performance and compliance of partners and distributors
Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV
Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities
Perform other duties as assigned

Requirements:

Masters in Clinical Research/PG Diploma in Clinical Research
3+ years of extensive, hands-on clinical trial and/or clinical settings of sponsor product
Experience with international and domestic regulatory submission, oncology experience, clinical trial experience

Nice to have:

Domain expertise in Cell Therapies, CAR-T, biologics manufacturing
Excellent verbal, written, presentation and interpersonal skills
Strong analytical and problem-solving skills
Proactive, creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Ability to work independently and as part of a team
Ability to manage multiple projects simultaneously
Strong attention to detail
Ability to work under pressure

Additional Information:

Job Posted:
June 03, 2025

Expiration:
July 20, 2025

Employment Type:

Fulltime

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Project Manager