Manager Clinical Researchrajeshlohakare
The Manager, Clinical Research will oversee the operational aspects of AVITA’s clinical trials while managing and developing the Clinical Research staff.
- Plan and manage clinical research activities from protocol development through final clinical study report submission.
- Proactively manage project level operational aspects of clinical research including management of trial timeline, budget, resources and vendors.
- Provide efficient updates on trial progress including patient recruitment, trial budget and overall timeline management.
- Lead vendor selection for clinical studies.
- Oversee and foster relationships with CROs.
- Ensure potential study risks are escalated when appropriate.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member.
- Author and review study protocols, study plans, IDE annual reports and clinical study reports.
- Mentor and provide guidance to clinical research staff.
- Provide study-related training internally and vendors and clinical sites.
- Review and approve vendor invoices to ensure clinical payments occur in a timely manner.
- Ensure compliance with regulatory requirements.
- Develop patient recruitment strategies and identify barriers to recruitment and propose solutions.
- Ensure consistency in processes across all programs and strict adherence to WIs/SOPs, regulations and guidelines.
- Maintain and/or accelerate timelines for achieving clinical research milestones.
- Perform other duties as requested.
- 6+ years clinical research experience
- 2+ year manager level experience
- 4+ years vendor/CRO management experience
- Commitment to excellence and high standards
- Flexibility and a proactive orientation
- Excellent organizational skills along with strong attention to detail
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Proficiency with Word, Excel, Power Point
- Ability to work independently and collaboratively in a dynamic, fast-paced, timeline-based environment
Bachelor’s Degree or is required.
Ability to travel and support clinical research off-site meetings and events is required (approximately 10%).