Novotech is a premier Asia-Pacific biotech specialist Contract Research Organization (CRO) with a strong presence across 11 geographies, including the United States, UK, and Asia-Pacific regions. With over 2,750 dedicated professionals and extensive experience in conducting more than 3,700 clinical projects, Novotech provides comprehensive clinical development services. These services span all clinical trial phases and therapeutic areas, including feasibility assessments, regulatory submissions, data management, statistical analysis, medical monitoring, and more. Holding ISO 27001 and ISO 9001 certifications, Novotech ensures top-notch quality and security standards for its clients and patients.
As a proud employer of choice, Novotech fosters an inclusive workplace, offering flexible work options, wellness programs, and development opportunities for all team members, including those identifying as LGBTIQ+ or with disabilities.
Responsibilities in Job
As a Clinical Data Manager (CDM) at Novotech, you will be integral to the data management group, ensuring adherence to Good Clinical Data Management Practices (GCDMP). Key responsibilities include:
- Data Management Oversight: Plan, conduct, and manage all aspects of data management for clinical trials in compliance with client specifications, protocols, project plans, and SOPs.
- Project Feasibility: Evaluate project feasibility from a data management perspective and collaborate with the Project Manager to mitigate risks and set contingencies.
- Standalone Projects: Act as the Project Manager for standalone data management projects, ensuring successful execution.
- Client Liaison: Work closely with clients and project teams to develop and maintain Data Management Plans.
- Proposal Input: Contribute to the preparation of RFPs in collaboration with the Business Development and clinical teams.
- Team Collaboration: Participate in project team meetings and provide updates as required.
Qualifications & Experience
To excel in this role, candidates should meet the following criteria:
- A graduate degree in clinical or life sciences-related fields.
- A minimum of 4 to 8 years of relevant experience in research, pharmaceutical, or related industries.
- Proficiency in data management practices and familiarity with regulatory requirements.
Skills
The ideal candidate should possess:
- Strong organizational and project management skills.
- Excellent communication and interpersonal abilities for client and team interactions.
- Analytical thinking to ensure compliance with data management protocols and GCDMP guidelines.
- Flexibility to adapt to project requirements and deadlines.