Sr. Clinical Trial Manager

As the Sr. Clinical Trial Manager at Enveda, your primary responsibilities include leading one or more clinical trials, ensuring that the execution of these trials aligns with the clinical development strategy, budget constraints, and timelines. You will be responsible for authoring and reviewing clinical trial documents, overseeing activities with Contract Research Organizations (CROs), and managing trial-related issues while maintaining compliance with all regulatory requirements.

To qualify for the Sr. Clinical Trial Manager role at Enveda, candidates typically need a B.S/B.A degree and a minimum of 5 years of experience in a pharmaceutical, biotech setting, or with a CRO. It is also essential to have at least 2 years of experience managing early-phase clinical trials, demonstrating strong knowledge of ICH/GCP and local regulations, as well as excellent communication skills.

Enveda stands out as a dynamic company where the culture emphasizes creativity, collaboration, and respect among team members. Our innovative approach to drug discovery, leveraging natural compounds, means that as a Sr. Clinical Trial Manager, you'll be at the forefront of transforming how we bring life-changing medications to market. Our impressive milestones and values highlight our commitment to both innovation and diversity.

Enveda offers an attractive benefits package for the Sr. Clinical Trial Manager position that includes 90% medical, dental, and vision coverage, a 401k match, flexible paid time off, and adoption assistance. These benefits reflect our commitment to supporting the well-being and professional growth of our team members.

To apply for the Sr. Clinical Trial Manager position at Enveda, interested candidates should visit our careers page where they can submit their application, including their resume and a cover letter. We encourage passionate individuals to apply, even if they do not meet every single requirement listed in the job description, as we value diversity and potential in our team.

In answering this question, reflect on your specific experiences and the types of clinical trials you have managed. It’s important to include details about the phases of the trials, your role in overseeing them, and any significant challenges you faced. Showcase your leadership skills and how you ensured compliance and adherence to timelines and budgets.

When answering this question, emphasize your thorough understanding of ICH/GCP guidelines and local regulations. Discuss specific strategies you employ, such as routine audits, keeping up-to-date with regulatory changes, and training team members to adhere to compliance protocols effectively.

In your response, highlight your communication and negotiation skills. Talk about your strategies for establishing clear expectations, regular check-ins, and how you address and resolve any trial-related issues collaboratively with CRO partners.

Discuss your problem-solving abilities and provide an example of a challenge you faced in a previous trial. Explain the steps you took to address the issue, involving team collaboration and stakeholder communication to find a resolution while minimizing impact on trial timelines.

Share a specific instance where you analyzed a process that was not functioning efficiently and the steps you took to implement a solution. This could involve streamlining documentation, enhancing communication protocols, or adopting new technologies that benefitted trial execution.

In your response, convey your prioritization methods, such as assessing critical milestones, resource availability, and timelines. Mention any project management tools or frameworks you utilize that help you maintain organization and efficiency across multiple trials.

Discuss core qualities such as strong leadership, excellent communication, attention to detail, problem-solving capabilities, and a deep understanding of clinical research regulations. Relate these qualities to your individual experiences and successes as a Clinical Trial Manager.

Address the importance of fostering a positive work environment. Share strategies you implement to keep your team motivated, such as recognizing achievements, encouraging open communication, and ensuring that team members feel valued and included throughout the trial process.

When answering this, reflect on Enveda's innovative approach to drug discovery. Comment on the company’s recognition and growth, as well as how its values align with your personal and professional goals in the field of clinical trials and pharmaceuticals.

Provide a specific example demonstrating your conflict resolution skills. Detail the situation, the differing viewpoints, the approach you took to mediate the discussion, and the outcome. Emphasize your ability to listen and facilitate collaboration to find common ground.