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- 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 dynamic work environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology.
- Qualifications: BSc in Life Sciences; experience in data management and understanding of GCP.
- Other info: Ideal for those passionate about data and its role in clinical research.
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.
- Create/review 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, & prioritise work on multiple projects.
- Ability to accurately estimate effort required for project related data management activities.
- Strong coaching, facilitation, and organisational 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 organisational 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
Network with professionals in the clinical data management field, especially those who have experience with oncology and diagnostic imaging. Attend relevant industry events or join online forums to make connections that could lead to referrals.
✨Tip Number 3
Brush up on your understanding of CDASH and CDISC standards, as well as SAS programming concepts. Being able to discuss these topics confidently will demonstrate your expertise and readiness for the role.
✨Tip Number 4
Prepare to showcase your ability to manage multiple projects and meet deadlines. Think of specific examples from your past experience where you successfully handled competing priorities, as this is a key requirement for the position.
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 how your background aligns with the responsibilities outlined in the job description. Mention specific experiences that demonstrate your expertise in data management and your ability to work in a fast-paced environment.
Showcase Relevant Skills: Highlight your understanding of CDASH and CDISC standards, as well as your knowledge of Good Clinical Practice (GCP) regulations. Provide examples of how you've applied these skills in previous roles to enhance your application.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in data management roles.
How to prepare for a job interview at Blue Earth Diagnostics
✨Showcase Your Technical Expertise
As a Senior Clinical Data Manager, it's crucial to demonstrate your knowledge of database design and data management processes. Be prepared to discuss your experience with EDC platforms like Medidata RAVE and your understanding of CDASH and CDISC standards.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past experiences where you had to manage vendor interactions or resolve data discrepancies, and be ready to explain your approach and the outcomes.
✨Highlight Your Cross-Functional Collaboration Skills
This role requires working closely with various teams and vendors. Share examples of how you've successfully collaborated in a matrixed environment, focusing on your communication and relationship-building skills.
✨Demonstrate Your Understanding of GCP Regulations
Since knowledge of Good Clinical Practice is essential, be prepared to discuss how you ensure compliance in your data management activities. Highlight any relevant training or certifications that showcase your commitment to maintaining high standards.
