What are the responsibilities and job description for the Medical Monitor（Autoimmune） position at InnoCare Pharma?
About the Company -
InnoCare Pharma is a cutting-edge bio-pharmaceutical company dedicated to advancing healthcare through innovative therapeutic solutions. We specialize in the discovery and development of novel small molecules, antibodies, and ADC for the treatment of various diseases cover therapeutic areas including oncology and immunology.
About the Role -
As a Medical Monitor role, this position need strong clinical medical & science background in advancing clinical development and registration successfully and efficiently.
Responsibilities -
- Designing and implementing phase I-II-III clinical trials in the field of autoimmune and / or Hema-oncology, based on ICH-GCP and relevant clinical research guidelines.
- Responsible for supervising clinical trials, ensuring that protocols, standard operating procedures SOP’s, good manufacturing practices (GCP) and regulatory requirements are followed.
- Building and maintain relationship with study investigators through regular communications and in-person visits.
- Collaborating with internal stakeholders and external partners in ensuring progress and delivery of clinical trials under defined timelines and with quality.
- Maintaining effective communication and cooperation with investigators, ethics committees, clinical research institutions, patient groups, and regulatory authorities at all levels in accordance with relevant policies and regulations.
- Medical development responsibilities, including medical monitoring and training during clinical trials; data integrity; data interpretation and analysis; participation in safety committees; communicating with regulatory authorities on medical related topics; and writing medical research documents for registration or publication.
- Medical support during the product development phase, including competitive landscape analysis, clinical development plan, product profile design, interpretation of literature data of the related field.
- Providing medical opinion for product portfolio, project development and BD opportunities.
Qualifications -
Doctor’s degree in Medicine (MD) required
Required Skills -
1. Minimum of 3 years’ direct experience of clinical trials in the field of autoimmune and / or Hema-oncology fields; familiar with design and execution of phase I to III trials.
2.Relevant work experience in study design, trial implementation, medical monitoring, data integrity and interpretation in a CRO, pharmaceutical or clinical trial environment required.
3.Knowledge of both local and global regulatory requirements as well as local and global GCP requirements.
4.Strong written and verbal communication and inter-personal skills to work with internal stakeholders or external partners.
5.Flexibility with work assignments and working hours; night-time TC with corporate functions in China.
6.Travel up to 10% of time.
Preferred Skills
Familiarity with Mandarin a plus
