Job overview:
we are seeking a seasoned data management professional to lead our team in delivering high-quality data management services.
* as a data team lead, you will be responsible for managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget.
* you will provide comprehensive data management expertise to the clinical data management (cdm) team to provide high-quality data management products that meet customer needs.
* you will also provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables.
key responsibilities include:
client management
* serving as primary point of contact for customers on data management deliverables.
* managing multiple large studies or programs of studies (possibly global).
* providing leadership and senior support to dtls on multiple large global studies/programs of global studies.
* providing project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
* leading direct negotiations with customers, e.g., timelines, financial, process, resources.
* maintaining strong customer relationships.
* ensuring open communications with customers and iqvia management to independently manage and meet contractual obligations.
service management
* meeting with data operations coordinator (doc) and/or data operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
* providing training and development on data management expertise to junior team members.
* establishing strong communications with data operations team, functional leads, project managers, and all other stakeholders.
* independently managing dm service delivery with comprehensive dm process and technical expertise in executing projects.
* serving as the escalation point for unresolved data issues.
* independently working with client data managers, vendors, internal team members for resolution.
* ensuring appropriate resources are assigned to meet project deliverables.
* creating and/or reviewing and signing off on all data management plan (dmp) documents.
* ensuring service and quality meet agreed-upon specifications per the dmp and contract/sow.
* implementing proactive quality management plans across multiple projects/programs/customer account.
* managing service performance and providing leadership to identify root causes of issues and implement remedial actions.
* continuously looking for opportunities to improve service.
* developing and working with team to implement plan to re-organize and drive change (possibly across a customer account).
* ensuring timely follow-up and resolution of compliance issues.
* serving as subject matter expert (sme).
* providing leadership and expertise in a specific cdm task or technology.
* serving as customer site lead for one or more customers.
* training and mentoring junior dtl staff in dm expertise.
* may coordinating the work of more junior dtl staff.
* independently maintaining internal tracking databases and systems.
financial management/business development support
* independently managing sow/budget.
* reviewing financial reports monthly and participating in project reviews as requested.
* identifying out-of-scope tasks and tracking change orders to completion.
* participating in pricing discussions across customer account.
* serving as project manager for single-service dm projects, including financial tracking, revenue recognition, and invoicing.
* independently supporting rfp process (review rfp documents, pricing, attending bid defense).
other
* independently bringing process improvements and solutions to the cdm team/cdm department.
* leading a focus team or global/local best practice team.
* communicating lessons learned and/or presenting in cdm workshops.
* managing the development and implementation of new technology or tool.
* presenting at professional conferences and/or publishing articles in professional journals.
* providing review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
* performing other duties as directed by the functional manager.
requirements:
bachelor's degree health, clinical, biological, or mathematical sciences, or related field req 7 years direct data management experience, including 5 or more years as a cdm project lead. Equivalent combination of education, training, and experience.
previous experience and proven competence in managing delivery of multiple global trials through full dm life cycle (i.e., large trials of at least 1000 patients).
demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in dm processes, sae reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently.
knowledge of medical terminology, pharmacology, anatomy, and/or physiology.
knowledge of operating procedures and work instructions and the ability to apply them in practice.
knowledge of good clinical practices and relevant regulatory guidelines.
comprehensive understanding of clinical drug development process.
ability to establish and maintain effective working relationships with coworkers, managers, and customers.