At a Glance
- Tasks: Provide medical guidance and oversight for clinical trials, ensuring safety and protocol compliance.
- Company: Join Alimentiv, a leader in pharmaceutical innovation and clinical research.
- Benefits: Competitive salary, professional development, and opportunities for impactful work.
- Other info: Collaborative environment with ongoing training and career growth opportunities.
- Why this job: Make a difference in patient safety and contribute to groundbreaking medical research.
- Qualifications: Medical degree with experience in drug development and clinical trials.
The predicted salary is between 36000 - 60000 £ per year.
This range is provided by Alimentiv. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings through the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report.
Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross‑functional teams as well as sponsor medical groups throughout the study.
Medical Oversight
- Provide clarity on general protocol questions, and medical guidance for protocols as required
- Serve as medical expert providing guidance on patient eligibility, and investigational product related questions
- Document contacts in accordance with Alimentiv or study specific procedures
- Consult with Alimentiv Medical Director(s), Sponsor Medical group and/or Safety about medical questions pertaining to the indication/compound under study
- Observe and identify safety issues and other trends as appropriate
- Provide consultation on the unbinding of trial participants/site staff to subject treatment allocation
- Review individual, out of range laboratory values following study‑specific laboratory guidelines and alert values (as appropriate).
- Review cumulative laboratory values according to the study plans
- Review protocol deviation data and recommend protocol changes as appropriate
- Create and follow a study‑specific medical monitoring plan if applicable
- Provide medical review of study level data, to identify gaps and areas requiring additional safety‑related follow‑up
- Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required
- Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.)
- Provide medical input into study feasibility, site selection and site initiations as required
- Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required
Knowledge
Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects.
Training
- Participates in the development and maintenance of medical educational materials
- Provide internal training to Alimentiv operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc., as needed to support execution of client studies or general acquisition to appropriate medical knowledge as required by the organization
- Assist with the development of investigator training and meeting support materials.
- Attend and present at investigator meetings and CRA training meetings
Qualifications
The successful candidate must have a medical degree with a strong understanding of the drug development process, ICH and Good Clinical Practices. Typically, this person will hold about 4-6 years of related experience with substantial on‑going job‑related training. Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel and prospective sponsors.
You must have the ability to exercise sound clinical judgment in addressing protocol ambiguities and unforeseen medical scenarios that arise during trial conduct. Strong analytical and critical thinking skills are essential for identifying safety signals, evaluating complex patient data, and recognizing emerging trends across study populations to ensure subject protection and data integrity. Previous experience in clinical trials is preferred especially in navigating complex medical scenarios within a CRO environment. Must be fluent in English.
Medical Monitor in Manchester employer: Alimentiv
At Alimentiv, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Senior TMF Lead, you will benefit from extensive professional development opportunities while working in a dynamic global environment that values your expertise and contributions. Our commitment to continuous improvement and employee well-being ensures that you will thrive both personally and professionally in this rewarding role.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Monitor in Manchester
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Alimentiv. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Alimentiv.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Alimentiv. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Alimentiv is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Medical Monitor in Manchester
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Alimentiv!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Alimentiv that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Alimentiv!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Alimentiv, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Alimentiv
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Alimentiv that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Alimentiv’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
