project manager - clinical operation.

Dear Candidates,

We are having opening for Clinical Operations - 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.

Interested candidates can share CVs at jhelam.s@randstad.in