At a Glance
- Tasks: Lead clinical site management for innovative studies and ensure timely deliverables.
- Company: Join AbbVie, a leader in healthcare innovation making a real impact on lives.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on collaboration and continuous improvement.
- Why this job: Be at the forefront of medical advancements and drive change in healthcare.
- Qualifications: Bachelor’s degree and experience in clinical research or project management required.
The predicted salary is between 51750 - 63250 £ per year.
About Abb Vie
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
For more information about Abb Vie, please visit us at www. abbvie. co. uk.
Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
- Company Description
- About Abb Vie
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
For more information about Abb Vie, please visit us at www. abbvie. co. uk.
Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.
Job Description
The Sr.
SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies.
The position is assigned to studies as the overall CSM functional study strategy leader and single point of accountability for study level CSM deliverables from study planning to close out.
Influences and aligns within Clinical Development Operations and other key stakeholders in assigned studies.
Accountable for planning and driving study-level CSM strategic planning and completion of deliverables by targeted timelines and with allocated resources for their assigned studies.
Directs and coordinates site management activities in collaboration with assigned SMLs managing area site execution activities if applicable.
Accountable for driving overall study level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
Responsibilities
- Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM.
Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones.
Accountable for study level site monitoring strategy, documented in Site Monitoring Plan.
Accountable to set and lead Site Engagement Strategy.
- Ensure study timelines are maintained across the study lifecycle. Provide timely and essential study information for country-level teams to execute milestones.
- Drive site-level activities at study level including site selection, activation, site engagement, protocol adherence and close out.
Oversee monitoring activities at study level in collaboration with assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable.
- Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan. Ensure sites are closed per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
Collaborate with assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
- Ensure site compliance, elevate issues, and analyze trends for continuous improvement.
- Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts.
- Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level.
Qualifications
- Bachelor’s Degree or equivalent OUS degree, typically in (para)medical or scientific field.
- Iindustry clinical research experience including monitoring or project management or equivalent experience on a global study. Global project management experience.
- Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients).
Experience in multiple therapeutic areas or disease state/indications highly desired.
- Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
- Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
- Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
- Demonstrated good written and verbal communication skills including fluency in English.
Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
- Able to work well within a team and autonomously. Thinks positively.
- Advanced skills in Microsoft Word, Microsoft Power Point, Microsoft Excel, Microsoft One Note
- Additional Information
Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www. abbvie. com/join-us/equal-employment-opportunity-employer. html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www. abbvie. com/join-us/reasonable-accommodations. html
- #J-18808-Ljbffr
Senior Site Management Lead in Maidenhead employer: AbbVie
AbbVie is an exceptional employer that prioritises employee well-being and inclusivity, particularly in our Maidenhead office, which features accessible facilities and a supportive work environment. We offer robust opportunities for professional growth and development, fostering a culture of collaboration and innovation that empowers our clinical research teams to excel. Join us to make a meaningful impact on patients' lives while enjoying a flexible hybrid work model and a commitment to diversity and integrity.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Site Management Lead in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like AbbVie. 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 AbbVie.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like AbbVie. 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 AbbVie is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Site Management Lead in Maidenhead
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 AbbVie!
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 AbbVie 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 AbbVie!
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 AbbVie, 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 AbbVie
✨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 AbbVie 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 AbbVie’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.
