One of the largest CROS in the global market is currently recruiting a Clinical Data Team Lead to their European team. This contract research organisation (CRO) is renowned for their work in technological advances and access to real-
world data. This is an exciting opportunity to become embedded in the wider clinical operations team and work on ground-breaking new medicine development.
The Clinical Data Team Lead will manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliberation on time and within budget, to customer satisfaction.
Job Responsibilities :
Serving as the primary point of contact for customer on data management deliverables
Providing project management expertise, working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalations, workload projections, and to provide technical expertise.
Providing justification for and performing direct negotiations with customer, e.g., timelines, financial, process, and resources.
Meeting with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
Establishing strong communications with Data Operations teams, functional leads, project managers, and all other stake holders.
Supporting DM service delivery with comprehensive DM process and technical expertise in executing projects.
Serving as the escalation point for unresolved data issues, work with client data managers, vendors, and internal team members for resolution.
Working with functional manager(s) to ensure 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 / programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
Serving as Subject Matter Expert (SME).
Providing leadership and expertise in a specific CDM task or technology.
Training and mentoring junior DTL staff in DM expertise, potentially coordinating the work of more junior DTL staff.
Maintaining internal tracking databases and systems.
Managing SOW / budget.
Reviewing financial reports on a monthly basis and participate in project reviews as requested.
Identifying out of scope tasks and tracking change orders to completion.
Serving as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
Participating in and supporting RFP process (reviewing RFP documents, pricing, and attend bid defence).
Independently bringing solutions to the CDM team / CDM department.
Leading and / or participating in a focus team or global or local best practice team.
Communicating lessons learned and / or present in CDM workshop(s).
Participating in the development and implementation of new technologies or tools.
Presenting at professional conferences and / or publishing articles in professional journals.
Providing reviews and input on developing, revising, and maintaining core operating procedures and work instructions.
Skills and Requirements :
Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field.
A minimum of 5 years direct Data Management experience, including 3 or more years as a CDM project lead or equivalent combination of education, training, and experience
Previous experience and proven competence in managing delivery of multiple projects through full DM lifecycle (several studies / programmes).
Demonstrated expert data management skills and thorough 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 of handling customer negotiations.
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.
Ability to work independently with available resources, e.g., functional managers, senior DTLs.
Comprehensive understanding of clinical drug development process.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.