Alpha MD is seeking a Clinical Research Associate/Study Manager to manage and oversee clinical trials across all phases (I-IV), post-marketing surveillance (PMS) studies, and real-world evidence (RWE) studies. The role involves comprehensive trial management, including budgeting, contract negotiation, and ensuring compliance with all relevant guidelines and regulations.
Key Responsibilities:
- Trial Management: Lead trial activities including budgeting, bid defense meetings, and agreements.
- Primary Contact: Serve as the main point of contact for trial-specific issues and deliverables.
- Team Coordination: Organize trial team meetings, provide updates, and maintain correspondence with stakeholders.
- Site Management: Identify and establish trial sites, train staff, ensure compliance, and document study-related activities.
- Monitoring and Compliance: Conduct site visits (in-person or remote), monitor compliance with SOPs, ICH, GCP, and local regulations.
- Documentation: Maintain and update study documentation and manage trial materials.
- Client and Site Relationships: Build relationships with clients and sites, negotiate contracts, and manage study agreements.
- Quality Control: Monitor the training, execution, and quality of study processes, facilitating client audits and inspections.
Qualifications:
- Education: Bachelor’s or Master’s degree in Pharma, Life Sciences, or related fields.
- Experience: 3-5 years of relevant experience.
- Skills:
- Proficiency in MS Office.
- Strong verbal and written communication in English.
- Excellent organizational, interpersonal, and team skills.
- Ability to work independently and manage multiple tasks.
- Strong attention to detail and ability to meet tight deadlines.
Desired Skills:
- Knowledge of the healthcare market and its challenges.
- Ability to manage a workload efficiently and adapt to team dynamics.
- Experience with contract negotiation and maintaining vendor/client documentation.
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