Principal Clinical Data Manager
hace 2 días
**Job Overview**:**
Principal Clinical Data Manager - FSPx**
**Home-Based**
Are you an experienced Clinical Data Manager who is now looking to take on more responsibilities in a Principal Clinical Data Manager opportunity? This is a great opportunity for someone who wants to advance their career, in a Sponsor dedicated role, whilst working alongside the leadership team in a technical and non-managerial DM role.
**Description**
- You will be permanently employed by Labcorp Drug Development working in our Flexible Solutions (FSPx) team, dedicated to one Sponsor and working across multiple therapeutic area.
- Office based or home based anywhere in Europe.
- You must have previous experience of working in a lead clinical data management role.
Joining Labcorp Flexible Solutions (FSPx) will further your career and offer a chance to work in an energetic & team-oriented workplace. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalised development planning.
Our unique opportunity will allow you to bring your specialized discipline to a core team, outsourced to a world leading, global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support from Senior Managers and our client project teams.
**Your Opportunity**:
The Principal Clinical Data Manager role is a great opportunity to work within our sponsor dedicated team and have this unique relationship with a sponsor. You will also work alongside the leadership team to provide guidance, mentoring and training to the DM team. You will lead multiple studies and take responsibility for the development of project documentation, system set up, data entry & validation.
By joining Labcorp, you will become a key member of the DM team, joining bid defenses, leading Sponsor engagements and capabilities presentations.
Duties will include:
- Lead a variety of complexed studies, including healthy volunteer and patient populations, multi-site, involving complex protocol design.
- Be accountable for all DM deliverables, as assigned per timeline, providing instruction to their DM study team and reviewing completed work.
- Ensure all projects are completed according to relevant protocols, SOPs and GCP standards.
- Work with Project Managers to build timelines to meet contracted milestones via communication with other Data Managers and during study initiation meetings.
- DM project leadership and accountability, lead DM internal meetings, meet frequently with study leads of EDC Design, SAS Programming, Stats & PK to ensure all deliverables are planned and coordinated.
- Identify risks/mitigations, effectively communicates to ensure database lock dates are achieved.
- Develop and maintain client relationships, drive process improvements and team training.
- Support Managers with regards to performance evaluation of other team members, aid their career development.
- Support budget development process for DM opportunities.
**Education/Qualifications**:
Additional relevant work experience will be considered in lieu of formal qualifications.
**Experience**:
- Extensive work experience in data management, including direct sponsor management and technical mentoring experience.
- Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives to encourage team members to seek solutions.
- Excellent oral and written communication and presentation skills.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
- Demonstrated managerial and interpersonal skills.
**MORE INFORMATION AVAILABLE ON REQUEST**
For a confidential discussion about this opportunity, please phone Antony McAteer on
+44 (0) 7800 913 717
. To apply, please click on the APPLY button.
**Keywords**:
Labcorp Drug Development, Covance by Labcorp, Covance, Chiltern, single sponsor, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data manager, clinical data management, Senior clinical data manager, Clinical Data Management, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Maidenhead, Reading, Berkshire, Birmingham, Cambridge, Sheffield, Manchester, Alderley Edge, Scotland, Edinburgh, Wales, Swansea, Northern Ireland, Austria, Belgium, Bulgaria, Czech Republic, France, Paris, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Leiden, Poland, Portugal, Romani
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