Study Start Up Specialist

As a Study Start-Up Specialist at Alimentiv, your primary responsibilities include supporting project management and regulatory activities, establishing relationships with study site personnel, and acting as the main contact during the site start-up process. You'll be preparing and following up on crucial start-up documents, planning and tracking site activities, and maintaining site intelligence to ensure successful timelines and compliance.

To qualify for the Study Start-Up Specialist role at Alimentiv, candidates should have a minimum of one to three years of related work experience, or a one-year College Advanced Diploma/Degree in a relevant field such as Health or Life Sciences, or Clinical Research. Strong communication skills and knowledge of clinical site start-up requirements are essential, along with experience working directly with study sites.

The Study Start-Up Specialist at Alimentiv collaborates closely with various departments including Project Management, Regulatory Affairs, and Contract and Legal teams. This collaboration is key to negotiating contracts, managing site budgets, and ensuring that all documentation and regulatory requirements are met efficiently and within the established timelines.

Successful Study Start-Up Specialists at Alimentiv must exhibit excellent communication skills, a strong sense of urgency, and a keen understanding of start-up requirements for clinical sites. Additionally, prior experience in clinical studies and the ability to maintain effective relationships with diverse stakeholders are crucial for thriving in this role.

The Study Start-Up Specialist position at Alimentiv is home-based, providing flexibility in work arrangements. The salary range for this role is competitive, ranging from €39,500 to €66,000 annually, plus a bonus structure, allowing you to enjoy a rewarding career while contributing to significant advancements in healthcare.

In my opinion, the most important qualities for a Study Start-Up Specialist include strong organizational skills, excellent communication abilities, and a proactive approach to problem-solving. Being detail-oriented is vital for ensuring compliance and accuracy in documentation, while the ability to build relationships with study sites fosters a collaborative work environment.

Certainly! I have previously worked directly with clinical study sites where I managed documentation, tracked progress, and facilitated communication between the team and the sites. This experience taught me the importance of timely follow-up and maintaining positive relationships to support efficient site start-up activities.

I prioritize tasks based on deadlines and the specific needs of the study sites. I create a comprehensive checklist and timeline for each project's requirements, ensuring that I address critical documentation and regulatory milestones first. Efficient time management is essential in keeping everything on track.

To maintain effective communication with study sites, I utilize various tools, including regular email updates, calls, and virtual meetings. I also ensure that I am approachable and responsive to any inquiries they may have, building trust and fostering collaboration throughout the start-up process.

When challenges arise during the start-up phase, I remain calm and solutions-oriented. I analyze the issue at hand, consult with relevant stakeholders, and seek to find a resolution that aligns with project goals. Maintaining a positive attitude and being adaptable is crucial during these times.

Start-up metrics are vital for measuring the efficiency and progress of site activities. They inform my work by providing insights into timelines, budget considerations, and overall site performance. I regularly analyze these metrics to identify trends and adjust our strategies to enhance efficiency and achieve project goals.

In my previous roles, I was involved in reviewing and negotiating contracts with study sites. I collaborated with legal teams to develop favorable terms and ensured that both the company's and the site's needs were met. My experience in this area has equipped me with strong negotiation skills and the ability to navigate complex discussions.

I ensure compliance with local regulatory requirements by staying informed about the latest regulations and guidelines relevant to clinical studies. I maintain thorough documentation and engage with regulatory affairs teams to ensure that all necessary approvals are obtained before moving forward with site activities.

Building strong relationships with new study sites requires open communication, transparency, and trust. I make it a priority to engage with sites early in the process, understand their needs, and provide ongoing support throughout the start-up phase. Personalized engagement helps foster a strong partnership.

I am drawn to Alimentiv's commitment to advancing healthcare solutions and improving patient outcomes. The opportunity to work in a dynamic environment where collaboration and innovation are valued aligns perfectly with my career aspirations. I am excited about the prospect of contributing to impactful clinical research initiatives.