New
Job ID : JO00171

Project Manager or Assistant Project Manager - Clinical Data Management Manager

  • Mumbai
  • 1 week ago

Job Description

Job Requirements:

  • 3+ years of extensive, hands-on clinical trial and/or clinical settings of sponsor product 
  • Domain expertise in Cell Therapies, CAR-T, biologics manufacturing is plus.
  • 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. 
  • Ability to work under pressure.
  • 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
Job Responsibilities:
  • To build a good understanding of the Indian oncology space, cancer-site-specific patient burdens, operational details of the CART treatment and patient requirements.
  • Be responsible for the data management of specific clinical studies
  • Review and maintain data management documentation, record management systems and identify tracking tools
  • Assist in the review and approval of study case report forms (CRFs) and related databases for the safe storage of information
  • Ensure the accuracy and integrity of data collected from clinical trials
  • Provide clinical knowledge when document amendments and updates to findings are required
  • Prepare reports and organize presentations or meetings about clinical trial progress
  • Overall maintain the Clinical plus commercial operations data 


Job Requirement


Additional Information

Job Type : Full Time
Experience : 3 - 8 years
Location : Mumbai, India
Qualification :

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