Clinical Research Project Manager / Project Lead
Department: Clinical Operations
Project Location(s): Bengaluru, India
Education: MBBS/BDS/BHMS/BAMS or Master’s Degree in Pure Science, Life Sciences, Pharmaceutical Sciences or Allied Sciences
Compensation: As per industry standards
Responsibilities
- Oversee multiple projects independently and with complete accountability
- Manage Project Teams
- Accountable for Quality, Time and Budgets for the projects
- Review of Clinical Trial documents (like Study Protocols, Informed Consent Documents, Case Report Forms, Investigator’s Brochure etc.) on available templates.
- Review CTD Modules
- Negotiate Clinical Trial Agreements and negotiate budgets with sites
- Oversee and interpret Study feasibilities collected from Sites
- Oversee of Pre-study and Post study duties
- Review documents for Ethics Committee and Regulatory Submissions
- Liaison with Regulatory Agencies
- Train the Site Staff on study related procedures and GCP and regulations
- Prepare Presentations for Investigator Meeting and Regulatory Agencies
- Review Site Selection, Study Initiation, Routine Monitoring and Close-out Visit Reports
- Coordinate Safety Reporting and ensure proper reporting to competent authorities
- Work closely with sponsors and Principal Investigators
- Ensure Data verification, collection of complete data, support cleaning, analysis of data and compilation of report
- Ensure Investigational Product Management and control
- Review and ensure the completeness of in-house Trial Master Files containing the essential documents the oversee the maintenance at the site
- Good understanding of applicable regulations and guidelines prevailing for clinical research
- Ensure that projects are efficiently delivered in strict adherence to study protocols, SOPs, ICH GCP, applicable national and international regulations, and Declaration of Helsinki.
- Committed to smooth and timely delivery of projects assigned
- Travel as may be required
- Mentor Trainee CRAs/CRCs
- Prepare Clinical SOPs
- Prepare training materials
- Help in regulatory filing
- Participate in business meetings as and when required
- Accomplish jobs assigned from time to time to meet satisfaction of the management
- Work in alignment with the firm’s objectives and common goal of the firm
Skills/Experience
- 6-9 years of on-the-job experience in clinical research industry
- Trained on current Good Clinical Practices guidance and local and global regulatory requirements for clinical research.
- Self -motivated, research oriented, highly organized, strong analytical and problem-solving skills.
- Understanding of mathematical and statistical analysis of clinical data and reports
- Exposure to software solutions for Trial Management.
- Excellent computer skills, proficiency in Microsoft office tools and especially excel spread sheet is an absolute must
- Solid Verbal and written communication skills necessary to interact smoothly with healthcare professionals and scientific community
- Multi-tasking and excellent time management skills