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 India’s first indigenously developed CAR-T therapy for the treatment of refractory/relapsing B-cell 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 / multi-center 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 CAR-T access to patients.
- Training of clinicians / nurses and hospital staff on CAR-T / drug related procedures. A good hands-on 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.
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 CAR-T 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/PG Diploma in Clinical Research/ biotechnology / related area
- 4+ years of extensive, hands-on clinical trial and/or clinical settings in reputed organization
- Experience with clinical trial experience, data collection, filing and management would be preferred
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.
- Strong analytical and problem-solving 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.
