At a Glance
- Tasks: Lead clinical data management activities and ensure compliance across multiple CROs.
- Company: Join a leading company in clinical data management with a commitment to innovation.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for continuous improvement and industry engagement.
- Why this job: Make a real impact in clinical trials and contribute to groundbreaking healthcare solutions.
- Qualifications: Bachelor's degree and 6+ years in Clinical Data Management, with strong RAVE experience.
The predicted salary is between 48000 - 72000 £ per year.
The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, and data management plan, and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs.
Responsibilities
- Independently lead data management study activities, CRO oversight, and driving deliverable timelines.
- Strong knowledge of EDC builds utilizing RAVE.
- Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provides input to functional governance with client strategic suppliers.
- Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Participates and represents function in formal inspections and audits as requested.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
- Acts as a process expert for operational and oversight models.
- Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
- May prepare metrics to support the function’s KPIs.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
- Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
- Utilizing your strong communication skills to present and explain data management concepts and consequences of decisions.
- Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience.
Qualifications
- Bachelor's Degree in a science, health related, or information technology field required.
- Minimum 6 years experience in Clinical Data Management with at least 3 as a Lead.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Senior Clinical Data Manager- FSP employer: Cytel
Cytel Inc. is an exceptional employer that fosters a collaborative and innovative work culture, providing Senior Clinical Data Managers with the opportunity to lead impactful projects across multiple CROs. With a strong commitment to employee growth, we offer continuous learning opportunities and support for professional development, ensuring our team members are well-equipped to excel in their roles. Located in a vibrant area, our company also promotes a healthy work-life balance, making it an ideal place for those seeking meaningful and rewarding employment in the clinical data management field.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Data Manager- FSP
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Cytel. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Cytel.
✨Leverage Internships for Full-time Roles
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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 Cytel is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Clinical Data Manager- FSP
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 Cytel!
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 Cytel 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 Cytel!
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 Cytel, 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 Cytel
✨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 Cytel 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 Cytel’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.
