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For Companies At a Glance
- Tasks: Lead data management for clinical trials, ensuring quality and compliance.
- Company: Join Blue Earth Diagnostics, a leader in innovative diagnostic solutions.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Make an impact in healthcare while developing your skills in a dynamic team.
- Qualifications: BSc in Life Sciences; experience in data management and understanding of GCP regulations required.
- Other info: Ideal for those passionate about oncology and eager to shape the future of diagnostics.
The predicted salary is between 48000 - 72000 £ per year.
Reporting to the Director of Biometrics, the Senior Clinical Data Manager (CDM) will primarily oversee the data management activities at Blue Earth Diagnostics. They will provide subject matter expertise in regard to database design, data transfers, vendor interactions and timelines. This includes authoring and/or reviewing documents in relation to database design, interim analyses and database locks. The CDM also serves as the point of contact for Data Management (DM) related activities with vendors, vendor selection/bid defense meetings and developing companywide DM standards library of Case Report Forms (CRF) and edit check specifications.
Main Responsibilities, Activities, Duties and Tasks
- Fulfil the role of lead data manager on all clinical trial projects as part of the biometrics team.
- Contribute to CRF Design and Edit Checks Development for Electronic Data Capture (EDC) platforms (e.g., Medidata RAVE).
- Review DM documentation including Data Management Plans, Data Transfer Specifications, Edit Check Specifications and support User Acceptance Testing (UAT).
- Actively participate in DM activities including cross-functional meetings and vendor management calls.
- Involved in developing Standards library for CRFs and Edit checks in relation to CDISC standards and Study Data Tabulation Model (SDTM) mapping for future trials.
- Provide support in data review and data reconciliation, and monitor the work performed by Clinical Research Organization (CRO) on data cleaning and data reconciliation until the end of the trial.
- Support the data review/cleaning in clinical studies e.g. creating internal checks using SAS or other programming software.
- Review study protocols, Statistical Analysis Plans, Tables/Listings/Figures, and CSRs.
- Creation/review of standard operating procedures related to data management.
- Provide internal data management training to other functions within Blue Earth Diagnostics as required.
- Input into and management of clinical study data management budgets for upcoming and ongoing clinical trials.
- Other duties as determined by business needs.
Education
BSc (Hons) Life Sciences or a related field.
Professional Experience, Knowledge & Technical Skills
- Extensive experience as a data manager at a pharmaceutical/biotechnology company or contract research organization.
- Experience working closely with outsourced study vendors.
- Good understanding of SAS programming concepts or other computing software.
- Good understanding of CDASH and CDISC Standards.
- Good understanding of the drug development process.
- Proficient understanding of DM processes and documentation.
- Knowledge of Good Clinical Practice (GCP) regulations/requirements.
- Oncology and diagnostic imaging experience.
Soft Skills – Company Values & Behaviours
- Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects.
- Ability to accurately estimate effort required for project related data management activities.
- Strong coaching, facilitation, and organizational skills; team player.
- Experience and skills with cross-functional and highly matrixed organizations.
- Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
- Strong coaching, facilitation, and organizational skills.
Senior Clinical Data Manager employer: Blue Earth Diagnostics
Contact Detail:
Blue Earth Diagnostics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager
✨Tip Number 1
Familiarise yourself with the specific EDC platforms mentioned in the job description, such as Medidata RAVE. Having hands-on experience or knowledge about these systems can set you apart during interviews.
✨Tip Number 2
Brush up on your understanding of CDASH and CDISC standards, as well as the drug development process. Being able to discuss these topics confidently will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Network with professionals in the clinical data management field, especially those who have experience with oncology and diagnostic imaging. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 4
Prepare for potential scenario-based questions during the interview that assess your problem-solving skills and ability to manage multiple projects. Think of examples from your past experience that showcase your organisational and coaching abilities.
We think you need these skills to ace Senior Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management, particularly in pharmaceutical or biotechnology settings. Emphasise your familiarity with database design, vendor interactions, and any specific software like SAS or EDC platforms.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that align with the responsibilities listed in the job description, such as your involvement in CRF design or managing data cleaning processes.
Highlight Relevant Skills: Clearly outline your understanding of CDASH and CDISC standards, as well as your knowledge of Good Clinical Practice (GCP) regulations. Use examples from your past work to demonstrate these skills effectively.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no spelling or grammatical errors, and that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in data management.
How to prepare for a job interview at Blue Earth Diagnostics
✨Showcase Your Expertise
As a Senior Clinical Data Manager, it's crucial to demonstrate your extensive experience in data management. Be prepared to discuss specific projects where you led data management activities, highlighting your role in database design and vendor interactions.
✨Familiarise Yourself with CDISC Standards
Since the role involves developing a standards library for CRFs and edit checks, make sure you understand CDISC standards thoroughly. Bring examples of how you've applied these standards in previous roles to the interview.
✨Prepare for Technical Questions
Expect questions related to SAS programming and data management processes. Brush up on your technical skills and be ready to explain how you've used programming software in data cleaning and reconciliation tasks.
✨Demonstrate Strong Communication Skills
Given the need to influence and build relationships across teams, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated with cross-functional teams and managed vendor relationships in past experiences.
