Jobs
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
- 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 | : |