Dear Candidates We are having opening for Clinical Operations Associate Project Manager 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 have a good coordination skill among internal and site stakeholders to run the clinical operations.
- Experience to run the clinical operations / multicenter clinical trials.
- Ensuring good documentation of ongoing clinical operation and coordination with sites to collect the patient data.
- Will be responsible for data collection management and filing / storage.
- Evaluating the site readiness and enabling the clinical sites for smooth CART access to patients.
- Training of clinicians / nurses and hospital staff on CART / drug related procedures. A good handson and communication skill is needed.
- Ensuring smooth coordination and communication between hospital logistics providers and internal stakeholders like manufacturing team.
- Build and lead a team of Product executives for each of the current hospitals in their zone.
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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.
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Qualifications and Educational Requirement |
- Masters in Clinical Research/PG Diploma in Clinical Research/ biotechnology / related area
- 4 years of extensive handson clinical trial and/or clinical settings in reputed organization
- Experience with clinical trial experience data collection filing and management would be preferred
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Desired Qualities |
- 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.
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Interested candidates can share CVs at
Regards
Jhelam
Randstad India