Principle Data Project Manager
- Experience Level
- Experienced (non-manager)
Joining Covance by 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 Principle 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.
- Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
- 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.
- Performs any CDM related ad-hoc requests from Line Manager or other senior managers.
- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
- Experience as a lead of a large Phase III trial or multiple smaller trials;
- Knowledge of SQL, 4GL, VBA or R software
- Experience of managing teams.