Clinical Trial Manager

As a Clinical Trial Manager, you will play a pivotal role in planning, executing, and overseeing clinical trials focused on ophthalmology. You will work in close collaboration with the Director, Clinical Operations to ensure the successful execution of assigned clinical trials.  This role reports into the VP, Clinical Operations. 

This is a unique opportunity to make a significant impact on the development of innovative therapies that have the potential to transform the field of ophthalmology.

Responsibilities:

• In conjunction with the Director, Clinical Operations, lead and manage the planning, execution and oversight of clinical trials, ensuring they are conducted in compliance with regulatory guidelines, company standards and timelines.
• Collaborate with medical and scientific teams to develop and refine clinical trial protocols, including trial design, patient eligibility criteria and clinical endpoints.
• Maintain a deep understanding of ICH GCP/global regulatory requirements and ensure that trials are Inspection Ready at all times.

• Input into trial budgets, including the allocation of resources and the negotiation of contracts with vendors and clinical research organizations (CROs).

• Identify and mitigate risks that could impact the successful execution of clinical trials and develop contingency plans as needed.

• Oversee activities and manage third-party vendors.
• Ensure the quality and integrity of clinical trial data by collaborating with data management teams and overseeing data collection.
• Oversee safety reporting and pharmacovigilance activities, including adverse event monitoring and reporting to regulatory authorities.

• Maintain open and transparent communication with internal and external stakeholders, including investigators, key opinion leaders and vendors.

• Oversee and ensure accurate and up-to-date documentation is always maintained in the Trial Master Files.

• Provide regular updates on trial progress for internally and external meetings.  
• Representing AAVantgarde externally at meetings and conferences.
  

 

Qualifications:  Skills and Capabilities

• Demonstrate flexibility, adaptability and professional maturity to understand priorities and anticipate needs proactively and readily. 
• Detail-oriented and highly organized, with the ability to manage multiple tasks simultaneously.
• Excellent problem-solving, decision making and negotiation skills.  
• Excellent communication skills both written and verbal, internal and external, working in a team as well as working independently.  
• Able to manage and promote KOL relationships.  
• Phase I & II experience desirable.
• Strong knowledge of regulatory requirements and GCP.
• Experience working in a startup environment or with biotechnology companies desirable.
• Willingness to travel as required for site visits, conferences and meetings.

 

Education and Experience:

• Ophthalmology and gene therapy experience desirable.
• Bachelor’s or Master’s degree in a related scientific discipline.
• Proven experience in clinical trial management.
• Highly proficient in Microsoft Office including Outlook, Word, Excel and PowerPoint. 

 

 

 

 

 

Equal Opportunities

 

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.

 

Recruitment Policy

 

AAVantgarde’s HR team leads all recruitment activities for AAVantgarde globally. AAVantgarde will not recognise any notional ownership recruitment companies claim to hold over candidates they present directly to hiring managers without the AAVantgarde HR team’s consent, nor any fees the recruitment company may feel are due as a result of this. Unsolicited resumes sent to AAVantgarde from recruiters do not constitute any type of relationship between the recruiter and AAVantgarde and do not obligate AAVantgarde to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees. If you are interested in becoming a recruitment partner please email the HR team at recruitment@aavantgarde.com