Clinical Study Manager
At Roche, we are committed to making a meaningful difference in patients' lives through innovative healthcare solutions. As a Clinical Study Manager, you will play a crucial role in the development and execution of clinical trials that ultimately bring life-changing treatments to market. We are seeking a highly motivated and detail-oriented individual to join our team and help drive our mission forward. If you have a passion for improving patients' lives and possess the necessary qualifications and experience, we invite you to apply for this exciting opportunity.
- Develop and implement clinical trial strategies in alignment with company objectives and regulatory requirements.
- Act as the primary point of contact for all study-related activities, including communication with cross-functional teams and external stakeholders.
- Oversee the planning, execution, and monitoring of clinical trials to ensure they are conducted in compliance with GCP and applicable regulations.
- Manage study budgets, timelines, and resources to ensure successful completion of trials.
- Collaborate with internal teams and external partners to design and review study protocols, informed consent forms, and other study-related documents.
- Conduct risk assessments and develop risk mitigation strategies for clinical trials.
- Proactively identify and resolve issues or challenges that may arise during the course of a clinical trial.
- Ensure data integrity and accuracy through oversight of data collection, management, and analysis.
- Monitor study progress and provide regular updates to key stakeholders, including senior management.
- Participate in site selection, qualification, and training of study sites to ensure compliance with study protocols and regulations.
- Ensure compliance with applicable laws, regulations, and company policies.
- Contribute to the development and review of standard operating procedures (SOPs) and other relevant documents.
- Keep abreast of industry trends and developments related to clinical trial management.
- Mentor and provide guidance to junior team members.
- Represent the company at scientific conferences and meetings, as needed.
Bachelor's Degree In A Relevant Field, Such As Life Sciences, Pharmaceuticals, Or Clinical Research.
Minimum Of 3-5 Years Of Experience Managing Clinical Studies, Preferably In The Pharmaceutical Industry.
In-Depth Knowledge Of Good Clinical Practice (Gcp) Guidelines And Regulatory Requirements For Clinical Trials.
Strong Project Management Skills, Including The Ability To Develop And Manage Timelines, Budgets, And Resources.
Excellent Communication And Leadership Skills, With The Ability To Collaborate Effectively With Cross-Functional Teams.
Communication Skills
Project Management
Vendor Management
Data Analysis
Time Management
Budget management
Quality Control
Team Leadership
Risk assessment
Regulatory compliance
Clinical Trials
Protocol Development
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Critical thinking
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Study Manager in Subang Jaya, Selangor, Malaysia is between RM 7,000 to RM 14,000 per month. This may vary based on factors such as years of experience, education level, and the specific company or industry the individual is working in.
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Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.
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