Clinical Trial Manager

As a Clinical Trial Manager at Precision for Medicine, your primary responsibilities entail managing the operational delivery of clinical study elements, including site selection, startup, and monitoring execution. You will lead CRAs in maintaining oversight of site operations, ensuring regulatory compliance, and delivering high-quality outcomes. The role also involves identifying challenges to study timelines and collaborating with the team to implement creative solutions.

To be considered for the Clinical Trial Manager position at Precision for Medicine, candidates must possess a Bachelor’s degree in a science or health-related field and demonstrable experience managing clinical trials, particularly in oncology, in a CRO or Pharma environment. A solid understanding of GCP/ICH guidelines and the clinical development process is also essential.

Precision for Medicine fosters a culture of continuous growth and development for Clinical Trial Managers. From mentoring opportunities to collaborative partnerships across functional teams, the organization ensures that team members receive the necessary support and resources to thrive. This includes access to advanced training and the latest tools in clinical trial management.

A successful Clinical Trial Manager at Precision for Medicine should exhibit excellent organizational skills, the ability to communicate effectively, and a keen sense of risk management. Additionally, familiarity with CTMS, eTMF, and EDC systems is beneficial, along with strong interpersonal skills to foster positive relationships with stakeholders across various levels.

Yes, the Clinical Trial Manager position at Precision for Medicine is fully remote, available to candidates residing in the UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia. This flexibility allows you to manage trials while enjoying the benefits of a work-life balance that comes with remote work.

When answering this question, highlight any specific trials you've managed across multiple countries. Discuss the challenges you faced, such as regulatory differences, language barriers, and site engagement strategies. Emphasize your adaptability and successful outcomes to demonstrate your capability in managing such complexities.

In your response, detail your understanding of GCP and ICH guidelines, and how you put these principles into practice. Provide examples of how you maintained compliance during different phases of clinical trials and mention any proactive steps you take to stay updated on regulatory changes.

Discuss your systematic approach to identifying, assessing, and managing risks. Mention specific tools or methodologies you've used, such as risk assessment matrices or regular meetings to evaluate study progress, and how you implement proactive measures to reduce potential complications.

Emphasize your communication strategy by outlining how you tailor your approach depending on the audience. Show how you maintain open lines of communication with CRAs, sites, and sponsors, highlighting tools or platforms utilized for effective updates and information sharing.

Provide a compelling narrative of a significant challenge you've encountered, whether related to timelines, resource allocation, or stakeholder management. Detail the steps you took to address the issue and the outcomes, showcasing your problem-solving abilities.

Discuss your familiarity with data management systems and processes, explaining how you ensure data integrity and accuracy throughout the trial. Include examples of previous data cleaning activities and experiences with EDC systems to demonstrate your hands-on abilities.

Describe your organizational skills and the techniques you use to prioritize tasks effectively, such as creating to-do lists or using project management software. Give examples of how you handle shifting priorities without compromising quality or timelines.

Share your approach to site engagement, discussing techniques that encourage partnership and motivation among site staff. You may reference regular communication, training initiatives, or recognizing and addressing sites' specific needs to promote successful collaboration.

Highlight a specific situation where you took the initiative to mentor or train a junior team member. Discuss your approach, the skills you aimed to impart, and the positive outcome for both the individual and the team, showcasing your leadership qualities.

In your response, convey your passion for precision medicine and how you align with Precision for Medicine's mission and values. Discuss specific elements of the company, such as its focus on oncology and rare diseases, that resonate with your career aspirations and values.