Clinical Trial istant
Clinical Trial istant
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Job Description
We are having opening for Clinical Trial Assistant with a pioneering cell & gene therapy company currently in Phase II trials for Indias first indigenously developed CART therapy for the treatment of refractory/relapsing Bcell malignancies (HCAR19) located in Navi Mumbai.
Roles and Responsibilities
- To build a good understanding of the Indian oncology space cancersitespecific 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 CART 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.
- Ensuring smooth coordination and communication between hospital logistics providers and internal stakeholders like manufacturing team.
- Liaises with PPMC for quarterly manufacturing requirements for enrolled patients as well as planned enrollment.
- Build and lead a team of Product executives for each of the current hospitals in their zone.
Key Performance Indicators
- Meeting the clinical readiness of the site/hospitals
- Meeting regulatory requirements as per GLP/hospital ethics guidelines
- Training of the hospital personals (nurses/ other staff) on CART products infusion and management
- Positive satisfaction ratings from the clinical/hospital teams).
- Leadership qualities in terms of training and motivating direct reportees
- Stakeholder management internally and externally.
Qualifications and Educational Requirement
- Masters in Clinical Research/Regulatory Affairs/Project Management
- 2 years of extensive handson clinical trial and/or clinical settings of sponsor product
- Experience with international and domestic regulatory submission oncology experience clinical trial experience
Desired Qualities
- Domain expertise in Cell Therapies CART biologics manufacturing is plus.
- Excellent verbal written presentation and interpersonal skills.
- Strong analytical and problemsolving skills.
- Proactive creative selfmotivated flexible to work in a small company environment and assume a wide variety of tasks.
- Strong analytical and problemsolving skills.
- 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.
Jhelam
Randstad India
Employment Type
Full Time
Company Industry
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