Dear Candidates, We have an opportunity with a leading cell & gene therapy company, having developed India’s first indigenously developed CAR-T therapy for the treatment of refractory/relapsing B-cell malignancies (NexCAR19). It has an aggressive pipeline to leverage its indigenously CAR-T platform to treat various oncology and non-oncology related diseases. Roles and Responsibilities
- Assist in providing training to the hospitals for all the procedures related to administration of CAR-T therapy.
- Support training sessions for hospital staff (nurses and others) on CAR-T infusion.
- Maintain effective communication and manage stakeholder expectations.
- Help address challenges at treatment centers to ensure smooth clinical operations.
- Track patient enrollment and follow-up activities.
- Coordinate and support clinical operations related to CAR-T therapy.
- Review and update site visit reports; track and resolve site-related issues promptly.
- Collaborate with the accounting team to review vendor invoices and ensure timely payments.
- To train and manage the activities of CTA, CRA.
- Contribute to problem-solving with cross-functional study teams, including vendors, sites, and internal members.
- Coordinate with courier agencies for the shipment and support Senior Project Manager for all activities.
Qualifications and Educational Requirement
- Master’s in life sciences or equivalent field
- Minimum of 4+ years of experience in clinical operations within the biopharmaceutical or biotechnology industry.
- In-depth knowledge of Clinical trial regulations, guidelines.
- Strong understanding of the drug development process, including clinical trial design, Good Clinical Practice (GCP).
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
- Strategic mindset with the ability to think critically, anticipate challenges, and develop innovative solutions.
Desired Qualities
- 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.
- Excellent written and verbal communication skills.
- 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.
Interested candidates can share cvs at jhelam.s@randstad.in
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