Senior Clinical Data Manager/Principal Clinical Data Manager

Senior Clinical Data Manager/Principal Clinical Data Manager

Full-Time 48000 - 84000 Β£ / year (est.) No working from home possible
Precision Medicine Group

At a Glance

  • Tasks: Lead clinical data management for trials, ensuring quality and timely data handling.
  • Company: Join a dynamic team focused on innovative clinical research solutions.
  • Benefits: Enjoy remote work flexibility and opportunities for professional growth.
  • Other info: Remote positions available across several European countries.
  • Why this job: Make a real impact in healthcare while developing your skills in a supportive environment.
  • Qualifications: Bachelor's degree and experience as a Lead Data Manager required; strong communication skills essential.

The predicted salary is between 48000 - 84000 Β£ per year.

Position Summary:
The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. This is a remote position candidates can be based in: Serbia, Spain, UK, Hungary, Poland, Romania or Slovakia.
Essential functions of the job include but are not limited to:

  • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
  • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
  • May perform quality control of data entry
  • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
  • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
  • May assist in building clinical databases
  • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
  • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
  • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
  • Review and query clinical trial data according to the Data Management Plan
  • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
  • Run patient and study level status and metric reporting
  • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
  • Coordinate SAE/AE reconciliation
  • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
  • May assist with SAS programming and quality control of SAS programs used in the Data Management department
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
  • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
  • May review Request for Proposals (RFP), proposals, provide project estimates
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable
  • Trains and ensures that all data management project team members have been sufficiently trained
  • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
  • May present software demonstrations/trainings, department/company training sessions, present at project meetings
  • May require some travel
  • Perform other duties as assigned
  • Qualifications:
    Minimum Required:

  • Bachelors and/or a combination of related experience
  • Other Required:

  • Must have worked as a Lead Data Manager for a Clinical Research Organisation
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Able to handle a variety of clinical research tasks
  • Excellent organizational and communication skills
  • Professional use of the English language; both written and oral
  • Experience in utilizing various clinical database management systems
  • Broad knowledge of drug, device and/or biologic development and effective data management practices
  • Strong representational skills, ability to communicate effectively orally and in writing
  • Strong leadership and interpersonal skills
  • Ability to undertake occasional travel
  • Preferred:

  • Experience in a clinical, scientific or healthcare discipline
  • Dictionary medical coding (MedDRA and WHODrug)
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
  • Oncology and/or Orphan Drug therapeutic experience
  • #LI-NC1 #LI-Remote

    Senior Clinical Data Manager/Principal Clinical Data Manager employer: Precision Medicine Group

    As a Senior Clinical Data Manager/Principal Clinical Data Manager at our company, you will thrive in a dynamic remote work environment that fosters collaboration and innovation across multiple countries, including the UK. We prioritise employee growth through continuous training and development opportunities, ensuring you stay at the forefront of clinical data management practices. Our inclusive work culture values your contributions, offering a supportive atmosphere where you can make a meaningful impact on clinical trials and patient outcomes.

    Precision Medicine Group

    Contact Details:

    Precision Medicine Group Recruitment Team

    StudySmarter Expert Advice🀫

    We think this is how you could land Senior Clinical Data Manager/Principal Clinical Data Manager

    ✨Tip Number 1

    Network with professionals in the clinical data management field. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and practices. This can help you gain insights into what employers like us at StudySmarter are looking for.

    ✨Tip Number 2

    Familiarise yourself with the specific software and tools mentioned in the job description, such as EDC systems and SAS programming. Having hands-on experience or certifications in these areas can set you apart from other candidates.

    ✨Tip Number 3

    Demonstrate your leadership skills by sharing examples of how you've successfully managed teams or projects in the past. Highlighting your ability to oversee data management processes will resonate well with us when we review candidates.

    ✨Tip Number 4

    Stay updated on regulatory guidelines and best practices in clinical data management. Showing that you are proactive about your professional development can impress us and indicate that you are committed to maintaining high standards in your work.

    We think you need these skills to ace Senior Clinical Data Manager/Principal Clinical Data Manager

    Clinical Data Management
    Database Development and Testing
    Data Entry Quality Control
    CRF Specifications Development
    UAT (User Acceptance Testing)
    Edit Check Specifications
    Data Management Documentation

    Some tips for your application 🫑

    Tailor Your CV:Make sure your CV highlights relevant experience in clinical data management. Emphasise your role as a Lead Data Manager and any specific projects that align with the job description.

    Craft a Compelling Cover Letter:Write a cover letter that addresses the key responsibilities mentioned in the job description. Explain how your skills and experiences make you a perfect fit for the Senior Clinical Data Manager role.

    Highlight Relevant Skills:In your application, focus on essential skills such as proficiency in Microsoft Office, experience with clinical database management systems, and your understanding of CDISC standards. These are crucial for the role.

    Showcase Leadership Experience:Since the position requires strong leadership skills, include examples of how you've led teams or projects in the past. This will demonstrate your capability to manage and train clinical research personnel effectively.

    How to prepare for a job interview at Precision Medicine Group

    ✨Know Your Data Management Processes

    Familiarise yourself with the entire clinical trial data management process, from study start-up to post database lock. Be prepared to discuss your experience in managing these processes and how you ensure quality and compliance with SOPs.

    ✨Demonstrate Leadership Skills

    As a Senior Clinical Data Manager, showcasing your leadership abilities is crucial. Prepare examples of how you've led teams, managed timelines, and ensured project continuity in previous roles.

    ✨Be Ready for Technical Questions

    Expect questions about specific technical skills, such as database development, UAT, and medical coding. Brush up on your knowledge of clinical database management systems and be ready to discuss your proficiency in tools like SAS.

    ✨Showcase Communication Skills

    Effective communication is key in this role. Prepare to demonstrate how you've liaised with sponsors, vendors, and project teams. Highlight your ability to convey complex information clearly and concisely.