Senior Clinical Data Manager - Cirencester, UK
Corin, United Kingdom

Corin are seekingSenior Clinical Data Manager to lead all aspects of the clinical study data management process from study start up to post database lock for assigned projects including mentoring staff. The Senior Clinical Data Manager will have advance knowledge of all applicable standards, regulations, and guidance relating to clinical data management to comply with pre- and post-market clinical evidence generation requirements for medical devices ensuring that all Corin pre-market and post-market clinical investigations meet the requirements of all legal and regulatory obligations.

The position is preferred to be office based at CORIN Ltd (Cirencester, Gloucestershire), but there will be some flexibility for the right candidate.

The key responsibilities for the Senior Clinical Data Manager are to;

• Manage all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support.
• Manage the selection process for a Global Electronic Data Capture (EDC) system for Corin clinical studies.
• Plan, design, validate, verify and implement database or EDC systems to support clinical studies globally from a data management perspective

• Supervise and mentor Clinical Data Managers assigned to these studies.

• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors and statisticians.

• Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.

• Review and contribute to clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.

• Review and advise on CRF completion guidelines, prepare external data transfer specifications and other study documentation related to data management.

• Contribute to clinical data review for the global product portfolio and provide inputs for advanced analyses.

• Identify, manage and communicate risk to timelines, quality and budget.

• Contribute to the ongoing development of the Data Management department through process analysis and improvement, mentoring, system enhancement.

• Develop adequate data management plans for each study protocol in compliance with current regulations.

• Review existing clinical data management company SOPs and, provide inputs for improvements to be fully compliant with current standards and regulations (if needed).
• Effectively support regulatory and sponsor audits.

• Establish and maintain good working relationship with internal and external stakeholders.

Requirements

The ideal Senior Clinical Data Manager will be / have

• Degree educated or equivalent
• Extensive relevant experience of working with medical device clinical studies data management systems and database testing procedures, ideally including experience in orthopaedics.
• Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Study/Data Management Systems
• Proven ability to work at a senior level within a data management team and have strong track record of experience working with complex databases.
• A good level of French speaking and written skills would be highly advantageous
• A demonstrable understanding of the role of data management in contributing to the conduct of high-quality clinical studies and compliance with regulatory standards such as ICH-GCP, ISO 14155, Medical Device Directive (MDD) and Medical Device Regulation (MDR).
• Knowledge of regulations, standards and guidance pertaining for clinical data management in key markets such as the UK, EU, AUS and US, and expectations for clinical data systems including 21 CFR Part 11, CDASH and applicable data protection requirements.
• Be proficient in the use of Microsoft Office including advanced Microsoft Excel Spreadsheets
• Statistical analysis skills
• Highly motivated and flexible, with excellent organizational and time management skills
• Excellent written and verbal communication skills.
• Strong presentation skills to internal professionals and external collaborators
• Autonomy with proactive approach to learning and problem solving

Benefits

You will receive a competitive salary and annual bonus as well as;

• 25 days holiday plus bank holidays.
• Excellent pension up to 9.7% provided by Corin when you contribute 4%
• Life assurance (6x basic salary).
• Private medical insurance with BUPA for you and your family.
• Subsidi

Job Rewards and Benefits