Labcorp Drug Development
Joining Labcorp Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. 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 personalized development planning.
Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class 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 of both a dedicated Covance line manager and our client project teams.
The Senior Project Data Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor.
You will also be able to manage the oversight of activities in data management on large scale projects.
This role is a great opportunity to lead projects and being sponsor dedicated:
- Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level.
- Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects.
- Communicates and negotiates effectively with all other Program level team members. Primary point of contact for Clinical Data Management (CDM) at the Global Program Team (GPT) level.
- Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs, (i.e. ensuring consistency across data quality plans.)
- Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give guidance on company standards, processes, systems and expectations to external partners, internal partners and third-party vendors.
- Responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.
- Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
- Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.
- May act as a team leaders or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
- Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.
- Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections/audits and liaison with Clinical Quality Assurance.
- Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.
What is FSP?
At Labcorp Drug Development, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp Drug Development has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp Drug Development studies.
With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://drugdevelopment.labcorp.com/services/functional-service-provider.html
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- Experience as a lead of a large Phase III trial or multiple smaller trials.
- Understanding of global clinical development budgets and relationship to productivity targets.
- Thorough knowledge of effective clinical data management practices.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
- Excellent oral and written communication and presentation skills.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Demonstrated ability to handle multiple competing priorities.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Strong 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.
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, 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, Romania, Russia, Slovakia, Bloemfontein, Centurion, South Africa, Madrid, Barcelona, Spain, Ukraine, #LI-Remote, Remote, EMEA